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<![CDATA[GMP News]]> /en/gmp-news.html/do/rssfeed/all/true Fri, 16 Nov 2018 21:13:45 +0000 Seitbox® http://blogs.law.harvard.edu/tech/rss <![CDATA[EMA: Concept Paper for new GMP Annex on Importation]]> http://gmpupdate.swhosting6.de/en/gmp-news/gmp-aktuell/EMA-Concept-Paper-Annex-Importation.html EMA has released a concept paper on new guidance for importers of medicinal products. GMP/GDP Inspectors Working Group agreed to draft a specific guidance for import authorisation holders. This document most likely would take the form of a new annex (annex 21). The deadline for comments is 29 August 2015.

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Sun, 31 May 2015 22:00:00 +0000
<![CDATA[ICH: Agenda Papers for the upcoming ICH SC Meeting available ]]> http://gmpupdate.swhosting6.de/en/gmp-news/gmp-aktuell/ICH-Agenda-Steering-Committee.html The ICH Steering Committee (SC) will meet in Fukuoka, Japan from 6 to 11 June to discuss ongoing harmonisation activities. One item on the agenda is the development of the ICH Q12 Guideline on Lifecycle Management.

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Sun, 31 May 2015 22:00:00 +0000
<![CDATA[LOGFILE No. 20/2015 – Laboratory data management systems (LDMS)]]> http://gmpupdate.swhosting6.de/en/lead-article/gmp-aktuell/gmp-logfile-laboratory-data-management-systems.html Advantages of laboratory data management systems (LDMS)

An excerpt of the GMP MANUAL

by Dr. Ulf Fuchslueger

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Tue, 26 May 2015 22:00:00 +0000
<![CDATA[IPEC publishes position paper on EU Risk Assessment Guidelines for Excipients]]> http://gmpupdate.swhosting6.de/en/gmp-news/gmp-aktuell/IPEC-position-paper-risk-assessment-excipients-EU.html The IPEC Federation (International Pharmaceutical Excipients Council) has published a three-page position paper concerning the risk-based approach of the EU Guidelines following the principles of Quality Risk Management according to ICH Q9. The IPEC-paper applies to the community regulated under the EU Risk Assessment Guidelines.

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Sun, 24 May 2015 22:00:00 +0000
<![CDATA[EU: Responses to the public consultation on the revision of Annex 15]]> http://gmpupdate.swhosting6.de/en/gmp-news/gmp-aktuell/EU-comments-Annex15.html The European Commission has published the responses to the public consultation on the revision of Annex 15: Qualification and Validation.

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Sun, 24 May 2015 22:00:00 +0000
<![CDATA[FDA: Three Final Guidance Documents on Biosimilarity]]> http://gmpupdate.swhosting6.de/en/gmp-news/gmp-aktuell/FDA-biosimilarity-final-guidances.html Following a three years period since publishing the “Biologics Price Competition and Innovation Act” and therein the “Approval Pathway for Biosimilar Biological Products”, the FDA has now finalized the following three guidance documents on Biosimilars:

Guidance for Industry - Biosimilars: Questions and Answers Regarding Implementation of the Biologics Price Competition and Innovation Act of 2009

Guidance for Industry - Quality Considerations in Demonstrating Biosimilarity to a Reference Protein Product

Guidance for Industry - Scientific Considerations in Demonstrating Biosimilarity to a Reference Product.

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Thu, 07 May 2015 22:00:00 +0000
<![CDATA[LOGFILE No. 17/2015 – Types of Biotechnological Active Substances]]> http://gmpupdate.swhosting6.de/en/lead-article/gmp-aktuell/gmp-logfile-types-of-biotechnological-active-substances.html Types of Biotechnological Active Substances

An excerpt of the GMP MANUAL

by Dr. Rainer Gnibl

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Tue, 05 May 2015 22:00:00 +0000
<![CDATA[Reverse Osmosis in Ph. Eur. Monograph Water for Injections ]]> http://gmpupdate.swhosting6.de/en/gmp-news/gmp-aktuell/EDQM-Reverse-Osmosis-PhEur-WFI.html For many years now, discussions have been ongoing as to whether it is possible to include non-distillation technologies as a method for the production of Water for Injections (WFI). Following a number of consultations with its stakeholders, the Ph. Eur. is proposing a revision of the monograph for Water for Injections (0169) to take into account current manufacturing practices which use methods other than distillation to produce water of injectable quality. The draft of the monograph foresees production of WFI also by reverse osmosis, which may be single-pass or double-pass, coupled with other suitable techniques such as deionisation and/or ultrafiltration.

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Sun, 26 Apr 2015 22:00:00 +0000
<![CDATA[PIC/S adopts revised EU Annex 15]]> http://gmpupdate.swhosting6.de/en/gmp-news/gmp-aktuell/PICS-adoption-EU-Annex-15.html As announced on the website of the Pharmaceutical Inspection Co-operation Scheme (PIC/S), the PIC/S Committee, by written procedure, has adopted the revision of Annex 15 of the PIC/S GMP Guide. The document will enter into force on 1 October 2015, simultaneously to the EU revision of Annex 15.

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Mon, 20 Apr 2015 22:00:00 +0000
<![CDATA[LOGFILE No. 15/2015 – Reduce Human Error in a GMP Facility]]> http://gmpupdate.swhosting6.de/en/lead-article/gmp-aktuell/gmp-logfile-reduce-human-error.html Reduce Human Error in a GMP Facility

by Claire Newcombe, Applied Biopharm Consultancy, Shanon McKenna , PAREXEL, Anthony Newcombe, PhD, PAREXEL

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Tue, 14 Apr 2015 22:00:00 +0000
<![CDATA[LOGFILE No. 13/2015 – Continuous Manufacturing - the FDA Perspective ]]> http://gmpupdate.swhosting6.de/en/lead-article/gmp-aktuell/gmp-logfile-continous-manufacturing.html Continuous Manufacturing

– the FDA perspective on the future of medicinal product manufacturing –


by Dr. Sabine Paris

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Wed, 08 Apr 2015 22:00:00 +0000
<![CDATA[EU GMP: Final Annex 15 now published]]> http://gmpupdate.swhosting6.de/en/gmp-news/gmp-aktuell/EU-GMP-final-annex-15-october-2015.html The currently valid version of the EU GMP Guide  Annex 15 “Qualification and Validation” from 2001 will finally be replaced by 1 October 2015. This is when the now published revised Version of Annex 15 will enter into force. An update was more than necessary. Not only the new principles of ICH Q8, Q9, Q10 and Q11 constituted a new regulatory environment but also a continuous updating of Chapters of Part I of the EU GMP Guide or Annex 11 (computerised systems). Another important document to be mentioned in connection with the new Annex 15 is the EMA guidance on process validation. The changes now reflect the changed regulatory requirements and the latest state of technology in the pharmaceutical industry.

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Tue, 07 Apr 2015 22:00:00 +0000
<![CDATA[EC: Important Final Versions to GMP for excipients and GDP for APIs]]> http://gmpupdate.swhosting6.de/en/gmp-news/gmp-aktuell/GMP-excipients-GDP-active-substances-final-versions.2015.html After a two-year consultation period the European Commission published two important guidelines in the Official Journal of the European Union on 21 March 2015:

Guidelines on principles of Good Distribution Practice of active substances for medicinal products for human use

Guidelines on the formalised risk asssessment for ascertaining the appropriate good manufacturing practice for excipients of medicinal products for human use.

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Tue, 31 Mar 2015 22:00:00 +0000
<![CDATA[GMP MANUAL Update No. 21]]> http://gmpupdate.swhosting6.de/en/gmp-news-updates/gmp-aktuell/21-update-gmp-manual-online.html With this GMP MANUAL UPDATE you have direct access to all prime regulatory changes and to our GMP expert interpretations. Here are the new features at a glance:

 

GMP in Practice

3.C

Air cleanliness classes and grades

3.E

Barrier systems, isolators and safety cabinets

4.C

Hygienic Design in solids handling

4.I

Containment in solids handling

13.A

Packaging materials (new author)

19.J

Coding and serialisation of folding cartons

19.K

Outsourced activities

 

GMP Regulations

C.4.3

Chapter 3 Premises and equipment

C.4.5

Chapter 5 Production

C.6.1.1

Concept paper on the revision of annex 1 – manufacture of sterile medicinal products

C.12.1

Commission delegated regulation (EU) No 1252/2014 supplementing Directive 2001/83/EC for active substances for medicinal products for human use

C.19

EMA: Guideline on setting health based exposure limits for use in risk identification in the manufacture of different medicinal products in shared facilities

D.1.5.1

FDA: Current good manufacturing practice requirements for combination products – Draft guidance

E.3.D

ICH Q3D: Guideline for elemental impurities

E.12

ICH Q12: Technical and regulatory considerations for pharmaceutical product lifecycle management – Final concept paper

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Wed, 25 Mar 2015 23:00:00 +0000
<![CDATA[WHO: Proactive Strategies against Falsified Medicines]]> http://gmpupdate.swhosting6.de/en/gmp-news/gmp-aktuell/WHO-falsified-medicinal-products-proactive-strategies-report.html On 20 March 2015 the WHO has published a report on substandard/spurious/falsely-labelled/falsified/counterfeit medicinal products (SSFFCs). The report was developed during a Member State Meeting on SSFFC in October 2014 in Geneva, Switzerland. It includes recommendations for health authorities to detect and deal with actions, activities and behaviours that result in SSFFCs.

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Wed, 25 Mar 2015 23:00:00 +0000
<![CDATA[LOGFILE No. 11/2015 - Preventing Cross-Contamination]]> http://gmpupdate.swhosting6.de/en/lead-article/gmp-aktuell/gmp-logfile-preventing-crosscontamination.html Preventing Cross-Contamination

In a highly acclaimed talk held during our GMP Symposium, Richard Denk elucidated the risk factors for contamination and the influence of highly active substances.


by Susanne Sailer

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Tue, 24 Mar 2015 23:00:00 +0000
<![CDATA[ICH Q11: Contributions to the Q11 Q&A document]]> http://gmpupdate.swhosting6.de/en/gmp-news/gmp-aktuell/ICH-Q11-questions-answers.html In November 2014 the ICH Steering Committee endorsed an Implementation Working Group (IWG) tasked to develop a Questions and Answers document on ICH Q11 – Development and Manufacture of Drug Substances.

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Thu, 12 Mar 2015 23:00:00 +0000
<![CDATA[LOGFILE No. 09/2015 - Principles of blow-fill-seal technology]]> http://gmpupdate.swhosting6.de/en/lead-article/gmp-aktuell/gmp-logfile-blow-fill-seal.html Principles of blow-fill-seal technology

An excerpt of the GMP MANUAL


by Dr. Manfred Grüneberg

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Tue, 10 Mar 2015 23:00:00 +0000
<![CDATA[FDA: List of CDER Guidances for 2015]]> http://gmpupdate.swhosting6.de/en/gmp-news/gmp-aktuell/FDA-List-CDER-Guidances-2015.html The U.S. Food and Drug Administration (FDA) has published their yearly list of new and revised draft guidances CDER is planning to publish in 2015. The guidances are categorized in 14 different themes - from A (Advertising) to P (Procedural).

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Thu, 05 Mar 2015 23:00:00 +0000
<![CDATA[EMA: Work Plan of GMP/GDP Inspectors Working Group for 2015]]> http://gmpupdate.swhosting6.de/en/gmp-news/gmp-aktuell/EMA-Work-Plan-GMDPIWG-2015.html EMA has published the work plan of the GMP/GDP Inspectors Working Group for 2015. The plan covers the different tasks of the group, e.g. harmonisation of inspections, mutual recognition agreements (MRAs) (maintenance, extension of scope) and GMP/GDP topics.
The list of GMP documents for revision contains the usual suspects – like Annex 15, but also the totally new Annex 21 on importation of medicinal products.

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Thu, 05 Mar 2015 23:00:00 +0000
<![CDATA[LOGFILE No. 07/2015 - Project management of facility construction]]> http://gmpupdate.swhosting6.de/en/lead-article/gmp-aktuell/gmp-logfile-project-management.html Project management of facility construction

An excerpt of the GMP MANUAL


by Thomas Peither

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Tue, 24 Feb 2015 23:00:00 +0000
<![CDATA[FDA: New Draft Documents Related to Compounding]]> http://gmpupdate.swhosting6.de/en/gmp-news/gmp-aktuell/FDA-drafts-compounding-human-drugs.html The U.S. Food and Drug Administration (FDA) issued five draft documents related to drug compounding and repackaging to help entities in complying with important health provisions. The draft documents apply to outsourcing facilities, federal facilities, pharmacies and physicians. The new category of outsourcing facilities was created under the Drug Quality and Security Act (DQSA), enacted by Congress in November 2013.

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Tue, 24 Feb 2015 23:00:00 +0000
<![CDATA[LOGFILE No. 05/2015 - Qualification and ATP Classification]]> http://gmpupdate.swhosting6.de/en/lead-article/gmp-aktuell/gmp-logfile-qualification-and-atp-classification-of-lorries.html What you must know about qualification and ATP classification of lorries

by Thomas Peither

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Tue, 10 Feb 2015 23:00:00 +0000
<![CDATA[EU GMP: Concept Paper to Manufacture of Sterile Medicinal Products]]> http://gmpupdate.swhosting6.de/en/gmp-news/gmp-aktuell/EU-gmp-annex-1-concept-paper-sterile-medicinal-products.html The European Medicines Agency (EMA) has released a Concept Paper on the Revision of Annex 1 of the Guidelines on Good Manufacturing Practice – Manufacture of Sterile Medicinal Products which addresses the need to update Annex 1 of the European GMP Guide. Annex 1 is common to the Member States of the European Union/European Economic Area as well as to the participating authorities of the Pharmaceutical Inspection Co-operation Scheme (PIC/S).

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Tue, 10 Feb 2015 23:00:00 +0000
<![CDATA[FDA: Draft Guidance to 21 CFR 4 Combination Products]]> http://gmpupdate.swhosting6.de/en/gmp-news/gmp-aktuell/FDA-combination-product-cgmp-21-cfr-4-draft.html FDA has released a draft of the Guidance on cGMP requirements for combination products. The document is far more comprehensive than the actual version of 21 CFR 4 and consists of 46 pages.

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Thu, 29 Jan 2015 23:00:00 +0000
<![CDATA[EU GMP Guide: Chapters 3 and 5]]> http://gmpupdate.swhosting6.de/en/gmp-news/gmp-aktuell/EU-gmp-guide-chapters-3-5.html New versions of Chapter 3 (Premises and Equipment) and Chapter 5 (Production) have been published providing transitional arrangements for toxicological evaluation. The chapters are otherwise unchanged – apart from an editorial correction of footnote 2 in Chapter 5 – and become operational on 1 March 2015 for all other aspects.

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Thu, 29 Jan 2015 23:00:00 +0000
<![CDATA[LOGFILE No. 03/2015 - Effectively dealing with OOX Results]]> http://gmpupdate.swhosting6.de/en/lead-article/gmp-aktuell/gmp-logfile-03-oox-results.html Test results outside defined criteria (OOX)

by Dr. Markus Limberger

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Tue, 27 Jan 2015 23:00:00 +0000
<![CDATA[CFDA issues Good Supply Practice for Medical Devices]]> http://gmpupdate.swhosting6.de/en/gmp-news/gmp-aktuell/CFDA-good-supply-practice-medical-devices-2014.html China’s Food and Drug Administration (CFDA) has issued the country’s first Good Supply Practices (GSP) regulations that apply to all Class 1, 2 and 3 medical device distributors, as well as third-party logistics service providers for medical devices.

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Thu, 22 Jan 2015 23:00:00 +0000
<![CDATA[CFDA: Good Manufacturing Practice for Medical Devices revised]]> http://gmpupdate.swhosting6.de/en/gmp-news/gmp-aktuell/CFDA-gmp-medical-devices-revised-2015.html China’s Food and Drug Administration (CFDA) has revised the Good Manufacturing Practice for Medicinal Devices in accordance to the newly revised Regulations for the Supervision and Administration of Medical Devices and Administrative Measures for the Supervision of Medical Device Manufacturing.

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Thu, 22 Jan 2015 23:00:00 +0000
<![CDATA[CDER Launches New Office of Pharmaceutical Quality]]> http://gmpupdate.swhosting6.de/en/gmp-news/gmp-aktuell/CDER-new-office-pharmaceutical-quality.html FDA Center for Drug Evaluation and Research (CDER) launched an Office of Pharmaceutical Quality (OPQ) as part of its ongoing Quality Initiative. This new office plans to create a drug quality program as the programs the agency already has in place for drug safety and efficacy.

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Thu, 15 Jan 2015 23:00:00 +0000
<![CDATA[LOGFILE No. 01/2015 - GMP-Outlook 2015]]> http://gmpupdate.swhosting6.de/en/lead-article/gmp-aktuell/gmp-logfile-gmp-outlook-2015.html GMP-Outlook 2015: What to expect in the world of GMP?

by Thomas Peither

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Tue, 13 Jan 2015 23:00:00 +0000
<![CDATA[ICH Q3D Guideline final]]> http://gmpupdate.swhosting6.de/en/gmp-news/gmp-aktuell/ICH-Q3D-guideline-final.html The ICH Q3D Guideline on Elemental Impurities reached Step 4 of the ICH Process in December 2014 and now enters the implementation period (Step 5). The new guidance has been developed to provide a global policy for limiting metal impurities qualitatively and quantitatively in drug products and ingredients.

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Tue, 13 Jan 2015 23:00:00 +0000
<![CDATA[FDA: Release of Guidance Agenda 2015]]> http://gmpupdate.swhosting6.de/en/gmp-news/gmp-aktuell/FDA-guidance-agenda-2015.html The US Food and Drug Administration (FDA) has just released a list of all new and revised draft guidances it plans to release in 2015. The list is published on an annual basis by FDA's CDER.

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Thu, 08 Jan 2015 23:00:00 +0000
<![CDATA[GMP MANUAL Update No. 20 (online version only)]]> http://gmpupdate.swhosting6.de/en/gmp-news-updates/gmp-aktuell/20-update-gmp-manual-online.html What is new?

GMP in Practice

New Chapters:

  • Chapter 3 Premises
    • Chapter 3.J.6 Validation of a monitoring system in accordance with GAMP5
  • Chapter 13 Packaging
    • Chapter 13.D Blow-fill-seal technology (BFS technology)
  • Chapter 21 Active Pharmaceutical Ingredients
    • Chapter 21.G Biotechnological active substances

Updated Chapters:

  • Chapter 3 Premises
    • Chapter 3.J Pharma monitoring of HVAC systems
  • Chapter 14 Laboratory controls
    • Chapter 14.H Test Results outside defined criteria (OOX)

GMP Regulations

New Chapters:

  • Chapter C EU Directives and Guidelines
    • C.16 Directive 2009/41/EC on the contained use of genetically modified micro-organisms
    • C.17 Directive 2000/54/EC on the protection of workers from risks related to exposure to biological agents at work
  • Chapter F PIC/S Guidelines
    • F.25 PIC/S PE 011-1 Guide to GDP for Medicinal Products
  • Chapter H WHO Guidelines
    • H.3 Guidelines on Quality Risk Management
    • H.6 Guide on transfer of technology in pharmaceutical manufacturing

Updated Chapters:

  • Chapter A Information
    • A.2 GMP Abbreviations
    • A.3 GMP Glossary
  • Chapter H WHO Guidelines
    • H.1 GMPs for pharmaceutical products: main principles
    • H.2 GMPs for active pharmaceutical ingredients
    • H.4 Water for pharmaceutical use
    • H.5 GMPS for sterile pharmaceutical products
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Tue, 06 Jan 2015 23:00:00 +0000
<![CDATA[ICH Steering Committee Meeting in Lisbon]]> http://gmpupdate.swhosting6.de/en/gmp-news/gmp-aktuell/ICH-steering-committee-meeting-lisbon.html The ICH Steering Committee (SC) and its Expert Working Groups (EWGs) met in Lisbon, Portugal on November 8–13, 2014. The meeting was hosted by the European Commission and included over 300 participants.

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Mon, 15 Dec 2014 23:00:00 +0000
<![CDATA[EU: Delegated Regulation on GMP for APIs published]]> http://gmpupdate.swhosting6.de/en/gmp-news/gmp-aktuell/european-union-delegated-regulation-gmp-api.html Before the end of the year the European Commission has published the “Commission Delegated Regulation (EU) No. 1252/2014 supplementing Directive 2001/83/EC of the European Parliament and of the Council with regard to principles and guidelines of good manufacturing practice for active substances for medicinal products for human use”. The regulation was issued on 25 November 2014 in the Official Journal of the European Union and has entered into force on 15 December 2014.

The regulation is binding in its entirety and directly applicable in all Member States of the European Union.

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Mon, 15 Dec 2014 23:00:00 +0000
<![CDATA[EMA: Setting Health Based Exposure Limits]]> http://gmpupdate.swhosting6.de/en/gmp-news/gmp-aktuell/EMA-guidline-final-health-based-exposure-limits.html The EMA has published the final version of the „Guideline on setting health based exposure limits for use in risk identification in the manufacture of different medicinal products in shared facilities”. The document was long expected and aims to recommend an approach for deriving a scientifically based threshold value for individual active substances to be applied for risk identification.

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Mon, 08 Dec 2014 23:00:00 +0000
<![CDATA[EMA: Guideline on Biosimilars]]> http://gmpupdate.swhosting6.de/en/gmp-news/gmp-aktuell/ema-guideline-biosimilars-principles-2014.html A biosimilar is a biological medicinal product that contains a version of the active substance of an already authorised original biological medicinal product (reference medicinal product) in the EEA. The EMA has published a revised version of the guideline "Guideline on similar biological medicinal products". It outlines the general principles to be applied for similar biological medicinal products (also known as biosimilars) as referred to in Directive 2001/83/EC and includes the following categories:

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Tue, 02 Dec 2014 23:00:00 +0000
<![CDATA[Joint Regulator ANZTPA Shut Down]]> http://gmpupdate.swhosting6.de/en/gmp-news/gmp-aktuell/ANZTPA-TGA-medsafe-shut-down.html Officials of Australia and New Zealand have confirmed the plan to stop the development of the joint regulatory authority ANZTPA. The decision was taken following a comprehensive review of progress and assessment of the costs and benefits to each country.

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Thu, 20 Nov 2014 23:00:00 +0000
<![CDATA[EMA and FDA Discuss Reliance on GMP Inspections]]> http://gmpupdate.swhosting6.de/en/gmp-news/gmp-aktuell/EMA-FDA-mutual-reliance-gmp-inspections.html This month representatives of the FDA have met with their cross-agency team from the EMA, the European Commission and GMP experts form European Union Member States in London, in order to make progress on mutual reliance on GMP inspections. The event was the first face-to-face meeting of both complete teams to discuss how EMA and FDA can collaborate in the field of inspections.

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Thu, 20 Nov 2014 23:00:00 +0000
<![CDATA[LOGFILE No. 40/2014 - GMP-Compliant Documentation]]> http://gmpupdate.swhosting6.de/en/lead-article/gmp-aktuell/gmp-logfile-gmp-compliant-documentation.html GMP-Compliant Documentation

An excerpt from the GMP MANUAL

by Cornelia Wawretschek

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Tue, 18 Nov 2014 23:00:00 +0000
<![CDATA[CDER: Updated Lists of Guidance Documents]]> http://gmpupdate.swhosting6.de/en/gmp-news/gmp-aktuell/fda-cder-guidance-lists-2014.html The FDA has published the following two updated lists of guidelines:

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Thu, 13 Nov 2014 23:00:00 +0000
<![CDATA[LOGFILE No. 38/2014 - GMP Certificates: What do they prove?]]> http://gmpupdate.swhosting6.de/en/lead-article/gmp-aktuell/gmp-logfile-gmpcert.html GMP Certificates for API Manufacturers

An excerpt from the GMP MANUAL

by Dr. Stefan Kettelhoit

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Tue, 11 Nov 2014 23:00:00 +0000
<![CDATA[ISPE: Preventing Drug Shortages]]> http://gmpupdate.swhosting6.de/en/gmp-news/gmp-aktuell/ispe-drug-shortage-prevention-plan.html ISPE released its Drug Shortages Prevention Plan during the 2014 Annual Meeting in Las Vegas, Nevada. ISPE developed the plan in response to global regulatory interest in preventing drug shortages due to manufacturing and quality issues. The plan addresses shortages at both the product and process levels. It lays out how industry can best prevent drug shortages by identifying the root causes of supply disruptions and creating a quality culture that will ensure a robust, resilient and reliable supply of medications to patients worldwide.

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Mon, 10 Nov 2014 23:00:00 +0000
<![CDATA[MHRA: GMP Inspection Deficiencies 2013]]> http://gmpupdate.swhosting6.de/en/gmp-news/gmp-aktuell/mhra-review-deficiencies-2013.html MHRA just published inspection trend data from 2013. The report has been presented in a revised format, following comments from a stakeholder focus group. In addition to 2013 inspection deficiency data, the report also includes longer term trends in ‘top 10 deficiencies’ and highlights areas for continued focus.

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Thu, 30 Oct 2014 23:00:00 +0000
<![CDATA[LOGFILE No. 36/2014 - EDMF/ASMF and CEP]]> http://gmpupdate.swhosting6.de/en/lead-article/gmp-aktuell/gmp-logfile-edmf-asmf-and-cep.html EDMF/ASMF and CEP

An excerpt from the GMP MANUAL

by Dr. Stefan Kettelhoit

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Tue, 28 Oct 2014 23:00:00 +0000
<![CDATA[EMA: Reflection Paper on API Starting Materials]]> http://gmpupdate.swhosting6.de/en/gmp-news/gmp-aktuell/ema-reflection-paper-api-starting-materials.html This month the EMA released a “Reflection paper in the requirements for selection and justification of starting materials for the manufacture of chemical active substances”. It aims to clarify some of the expectations of EU competent authorities arising from the guidance found in ICH Q11 regarding the information to be submitted in marketing authorisation dossiers to justify the selection of starting materials.

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Mon, 27 Oct 2014 23:00:00 +0000
<![CDATA[FDA: Guidance for Industry on Drug Inspection]]> http://gmpupdate.swhosting6.de/en/gmp-news/gmp-aktuell/fda-guidance-drug-inspection.html On 21 October 2014, the FDA released the final version of its Guidance for Industry entitled „Circumstances that constitute delaying, limiting, or refusing a drug inspection”. Delaying, refusing, denying – FDA inspectors often see themselves confronted with cooperation problems. The guidance intends to clarify how the law under Section 707 of FDASIA (Food and Drug Administration Safety and Innovation Act) will be interpreted and put into practice by the FDA.

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Mon, 27 Oct 2014 23:00:00 +0000
<![CDATA[Final Concept Paper ICH Q12 to Pharmaceutical Product Lifecycle]]> http://gmpupdate.swhosting6.de/en/gmp-news/gmp-aktuell/ICHQ12-final-concept-paper-pharmaceutical-product-lifecycle.html The ICH Steering Committee has endorsed the final concept paper Q12 “Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management”. According to the ICH this new document shall provide guidance on a framework to facilitate the management of post-approval Chemistry, Manufacturing and Controls (CMC) changes in a more predictable and efficient manner across the lifecycle of a product.

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Mon, 20 Oct 2014 22:00:00 +0000
<![CDATA[LOGFILE No. 34/2014 - Safety in the workplace]]> http://gmpupdate.swhosting6.de/en/lead-article/gmp-aktuell/gmp-logfile-safety-in-the-workplace.html Safety in the workplace / Occupational health and safety

An excerpt from the GMP MANUAL

by Dr. Michael Hiob

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Tue, 14 Oct 2014 22:00:00 +0000
<![CDATA[WHO: Non-Sterile Process Validation]]> http://gmpupdate.swhosting6.de/en/gmp-news/gmp-aktuell/who-non-sterile-process-validation.html The World Health Organization (WHO) has published the revised draft of the Supplementary Guideline on Good Manufacturing Practices: Validation Appendix 7: Non-sterile Process Validation.

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Sun, 12 Oct 2014 22:00:00 +0000
<![CDATA[GMP MANUAL Update No. 19]]> http://gmpupdate.swhosting6.de/en/gmp-news-updates/gmp-aktuell/19-update-gmp-manual-online.html

What is new?

GMP in Practice

New Chapters:

  • Chapter 4 Facilities and Equipment
    • 4.A: Facility Planning
    • 4.B: Materials
    • 4.H: Cleaning of Facilities

Updated Chapters:

  • Chapter 4 Facilities and Equipment
    • 4.C Hygienic Design in Solids Handling (formerly 4.L, still under revision)
    • 4.D System Controllers and Process Control Systems (formerly 4.C and 4.K)
    • 4.E Technical Documentation (formerly 4.F)
    • 4.F Calibration (formerly 4.G)
    • 4.G Maintenance (formerly 4.H)
    • 4.I Containment (personnel protection) in Solids Handling
      (formerly 4.J, still under revision)

GMP Regulations

New Chapters:

  • Chapter C EU Directives and Guidelines
    • C.18 Guidance for the template for the qualified person’s declaration concerning GMP compliance of active substance manufacture “The QP declaration template”
    • C.18.1 Qualified Person’s declaration concerning GMP compliance of the active substance manufacture “The QP declaration template”

Updated Chapters:

  • Chapter C EU Directives and Guidelines
    • C.4 Part I Basic Requirements for Medicinal Products
      C.4.3.1 Chapter 3 Premises and Equipment (entry into force 1 March 2015)
      C.4.5.1 Chapter 5 Production (entry into force 1 March 2015)
      C.4.8.1 Chapter 8 Complaints, Quality Defects and Products (entry into force 1 March 2015)
      C.5 Part II Basic Requirements for Active Substances used as Starting Materials
      C.8.5.1 Importation of Active Substances for Medicinal Products for Human Use – Questions and Answers Version 5.0
  • Chapter D.1 Code of Federal Regulations
    • D.1.1 21 CFR Part 210
    • D.1.2 21 CFR Part 211
    • D.1.3 21 CFR Part 11
    • D.1.4 21 CFR Part 820
    • D.1.5 21 CFR Part 4
    • D.1.6 21 CFR Part 606
    • D.1.7 21 CFR Part 606
  • Chapter F PIC/S Guidelines
    • F.9 PIC/S PE 009-11 GMP Guide Introduction
    • F.10 PIC/S PE 009-11 GMP Guide Part I
    • F.11 PIC/S PE 009-11 GMP Guide Part II
    • F.12 PIC/S PE 009-11 GMP Guide Annexes
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Wed, 08 Oct 2014 22:00:00 +0000
<![CDATA[EDQM: New Webpage for the Certification Division]]> http://gmpupdate.swhosting6.de/en/gmp-news/gmp-aktuell/edqm-new-webpage-certification.html A new webpage has just been launched under the Certification of Suitability section of the website.

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Sun, 05 Oct 2014 22:00:00 +0000
<![CDATA[EDQM: Updated application forms for CEPs]]> http://gmpupdate.swhosting6.de/en/gmp-news/gmp-aktuell/EDQM-update-CEP-application.html The application forms for requests for certificates of suitability (CEPs) have been updated.

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Thu, 25 Sep 2014 22:00:00 +0000
<![CDATA[PIC/S: Croatia Applies for Membership]]> http://gmpupdate.swhosting6.de/en/gmp-news/gmp-aktuell/croatia-pic-s-application-membership.html Shortly before the next PIC/S Committee Meeting on 20-21 October 2014 in Paris, the Croatian Agency for Medicinal Products and Medical Devices (HALMED) applied for PIC/S membership.

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Thu, 25 Sep 2014 22:00:00 +0000
<![CDATA[EDQM: Symposium on Combating Counterfeits and Other Illegal Medicines]]> http://gmpupdate.swhosting6.de/en/gmp-news/gmp-aktuell/EDQM-symposium-counterfeits.html The use of products with non-declared pharmacological activity or “other illegal medicines”, often from uncontrolled sources but also purchased from the legal market, is still a major problem within Europe.

From 10-11 September 2014, the second symposium on combating counterfeits and other illegal medicines took place at EDQM. Representatives from forensic and customs laboratories, national medicines and food authorities, enforcement groups and the European Commission were invited to shed light on the problem of falsification of medicines.

 

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Mon, 22 Sep 2014 22:00:00 +0000
<![CDATA[ICH: Report of ICH Steering Committee]]> http://gmpupdate.swhosting6.de/en/gmp-news/gmp-aktuell/ICH-report-steering-committee.html A comprehensive report of the last ICH meeting, which was held in Minneapolis, MN, USA, on 4-5 June 2014, is now available on the ICH website under the SC Reports page.

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Mon, 22 Sep 2014 22:00:00 +0000
<![CDATA[FDA: SUN Pharma may face another Import Alert]]> http://gmpupdate.swhosting6.de/en/gmp-news/gmp-aktuell/FDA-SUN-pharma-import-alert-india.html According to the Indian financial portal Business Standard and Money Control, the US FDA has started a surprise audit at the Halol Plant of SUN Pharma on Monday 8, 2014.

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Thu, 11 Sep 2014 22:00:00 +0000
<![CDATA[APIC: eCTD How to do Document]]> http://gmpupdate.swhosting6.de/en/gmp-news/gmp-aktuell/APIC-ectd-how-to-do-document.html The Active Pharmaceutical Ingredients Committee, APIC, has recently published a comprehensive How to do Document regarding electronic Common Technical Documents. eCTD is a topic of increasing interest in the pharmaceutical environment. This guideline document focuses entirely on the first submission of an API dossier.

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Mon, 08 Sep 2014 22:00:00 +0000
<![CDATA[LOGFILE No. 28/2014 - Integrated Quality Risk Management]]> http://gmpupdate.swhosting6.de/en/lead-article/gmp-aktuell/gmp-logfile-integrated-quality-risk-management.html Integrated Quality Risk Management

An excerpt from the GMP MANUAL

by Martin Mayer

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Tue, 02 Sep 2014 22:00:00 +0000
<![CDATA[EU GMP Guide: Revision of Part II]]> http://gmpupdate.swhosting6.de/en/gmp-news/gmp-aktuell/EU-gmp-guide-revision-part-II.html The European Commission has published a revised version of Part II of the EU GMP Guide – Basic Requirements for Active Substances used as Starting Materials. According to the EC this became necessary due to changes in various Annexes of the GMP Guide. Hence Part I can no longer be followed for active substances used as starting materials.

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Mon, 01 Sep 2014 22:00:00 +0000
<![CDATA[EU GMP Guide: Chapters 3, 5 and 8 now final]]> http://gmpupdate.swhosting6.de/en/gmp-news/gmp-aktuell/EU-gmp-guide-chapter-3-5-8-final.html The European Commission has published the final version of the following revised chapters of the EU GMP Guide:

The deadline for implementation is 1 March 2015.

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Mon, 01 Sep 2014 22:00:00 +0000
<![CDATA[LOGFILE No. 26/2014 - Principles of Human Resource Management]]> http://gmpupdate.swhosting6.de/en/lead-article/gmp-aktuell/gmp-logfile-principles-of-human-resource-management.html Principles of human resource management

An excerpt from the GMP MANUAL

by Dr. Michael Hiob

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Tue, 19 Aug 2014 22:00:00 +0000
<![CDATA[EMA: Cooperation with international partners on generics]]> http://gmpupdate.swhosting6.de/en/gmp-news/gmp-aktuell/ema-cooperation-generics.html The EU’s decentralised procedure is being used as a model to accelerate the assessment of applications for generic medicines as part of the International Generic Drug Regulators PilotExternal link icon (IGDRP). The EU is leading an international pilot project through which, upon request from a generic pharmaceutical company, it will share the assessment reports generated as part of the decentralised procedure in real time with collaborating regulatory agencies outside the EU.

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Thu, 14 Aug 2014 22:00:00 +0000
<![CDATA[TGA: EU/ICH guidelines adopted]]> http://gmpupdate.swhosting6.de/en/gmp-news/gmp-aktuell/tga-eu-ich-guidelines-adopted.html Following consultation within the TGA and with relevant stakeholders including Industry and consumer groups, a number of EU/ICH Guidelines have been adopted by the TGA, effective 1 August 2014.

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Sun, 10 Aug 2014 22:00:00 +0000
<![CDATA[LOGFILE No. 24/2014 - Risk Assessment of Excipients]]> http://gmpupdate.swhosting6.de/en/lead-article/gmp-aktuell/gmp-logfile-risk-assessment-of-excipients.html Excipients – Risks and their Assessment

by Dr. Stephanie Blum

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Tue, 29 Jul 2014 22:00:00 +0000
<![CDATA[ICH: M7 Guidline reaches Step 4]]> http://gmpupdate.swhosting6.de/en/gmp-news/gmp-aktuell/ICH-M7-mutagenic-impurities-step-4.html The ICH M7 Guideline on Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risk has reached Step 4 of the ICH process and is now entering the implementation period (Step 5). The final draft isbeing recommended for adoption to the regulatory bodies of the European Union, Japan and the USA.

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Mon, 21 Jul 2014 22:00:00 +0000
<![CDATA[LOGFILE No. 22/2014 - Electronic Training Systems]]> http://gmpupdate.swhosting6.de/en/lead-article/gmp-aktuell/gmp-logfile-electronic-training-systems.html Electronic Training Systems

An excerpt from the GMP MANUAL

by Dr. Michael Hiob

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Tue, 15 Jul 2014 22:00:00 +0000
<![CDATA[FDA: List of Guidance Documents]]> http://gmpupdate.swhosting6.de/en/gmp-news/gmp-aktuell/fda-list-guidance-documents-2014.html FDAs Center for Drug Evaluation and Reseach (CDER) has published its yearly list of guidance documents and a list of new, revised and withdrawn guidances. This document provides a concise overview of the status of various guidelines that are currently in process:

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Sun, 13 Jul 2014 22:00:00 +0000
<![CDATA[FDA: Policy documents on compounded drug products ]]> http://gmpupdate.swhosting6.de/en/gmp-news/gmp-aktuell/fda-policy-documents-compounded-drug-products.html Last week the FDA issued several policy documents regarding compounded drug products for human use, as part of the agency’s effort to implement the compounding provisions of the Drug Quality and Security Act (DQSA), enacted in November 2013. The policy documents consist of a draft interim guidance, a proposed rule, a final guidance, and two revised requests for nominations for the bulk drug substances lists.

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Mon, 07 Jul 2014 22:00:00 +0000
<![CDATA[LOGFILE No. 20/2014 - Quality Assurance]]> http://gmpupdate.swhosting6.de/en/lead-article/gmp-aktuell/gmp-logfile-quality-assurance.html The Role of Quality Assurance within the Pharmaceutical Quality System

by Dr. Bernd Renger

 

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Tue, 01 Jul 2014 22:00:00 +0000
<![CDATA[Logo for authentic online pharmacies in Europe]]> http://gmpupdate.swhosting6.de/en/gmp-news/gmp-aktuell/logo-authentic-online-pharmacies-europe.html EU regulators have unveiled a new logo which will appear on the websites of all authorised online pharmacies known to provide authentic medicines. This represents one more step towards helping European consumers to avoid counterfeit or falsified medicines.

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Mon, 30 Jun 2014 22:00:00 +0000
<![CDATA[APIC publishes new documents]]> http://gmpupdate.swhosting6.de/en/gmp-news/gmp-aktuell/apic-how-to-do-gdp-cleaning-validation.html The Active Pharmaceutical Ingredients Committee (APIC) has recently released two new documents:

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Mon, 30 Jun 2014 22:00:00 +0000
<![CDATA[TGA joins EDQM's CEP assessment process]]> http://gmpupdate.swhosting6.de/en/gmp-news/gmp-aktuell/tga-collaboration-edqm.html The Australian Therapeutic Goods Administration (TGA) is set to strengthen its collaboration with the European Directorate for the Quality of Medicines and HealthCare (EDQM).

In May 2014 Australia was accepted as an assessor in the EDQM's procedure for the Certification of Suitability to the monographs of the European Pharmacopoeia (CEPs).

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Tue, 24 Jun 2014 22:00:00 +0000
<![CDATA[Update on Revision of EU GMP Documents]]> http://gmpupdate.swhosting6.de/en/gmp-news/gmp-aktuell/mhra-revision-eu-gmp-documents.html The British authority MHRA have published meeting minutes of their GMP/GDP Consultative Committee that took place on 11th April 2014 in London. Two times a year MHRA meets with different industry groups/associations to inform and discuss about latest GMP and GDP issues. Inter alia, MHRA gave an update on the GMP/GDP documents currently under revision or in preparation, respectively.

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Tue, 24 Jun 2014 22:00:00 +0000
<![CDATA[LOGFILE No. 18/2014 - Knowledge Management]]> http://gmpupdate.swhosting6.de/en/lead-article/gmp-aktuell/gmp-logfile-knowledge-management.html Knowledge Management is the Next Risk Management

by Thomas Peither

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Tue, 17 Jun 2014 22:00:00 +0000
<![CDATA[EMA: QP Declaration]]> http://gmpupdate.swhosting6.de/en/gmp-news/gmp-aktuell/ema-qp-declaration.html EMA has published the long awaited Qualified Person (QP) declaration template and accompanying guidance concerning GMP compliance of API manufacture. The much discussed draft version dates back to 2010.

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Mon, 16 Jun 2014 22:00:00 +0000
<![CDATA[GMP MANUAL Update No. 18]]> http://gmpupdate.swhosting6.de/en/gmp-news-updates/gmp-aktuell/18-update-gmp-manual.html What is new?

GMP in Practice

New Chapters:

  • Chapter 2 Personnel
    • Chapter 2.A Human Resource Management
    • Chapter 2.B Health Monitoring and Occupational Health and Safety
  • Chapter 19. Quality Unit
    • Chapter 19.A Quality Assurance Duties
  • Chapter 10 Quality Risk Management (formerly Considerations on Risk Management, completely new version)

Updated Chapters:

  • Chapter 2 Personnel
    • Chapter 2.C Training

GMP Regulations

New Chapters:

  • Chapter C EU Directives and Guidelines
    • C.4.3.1 EU-GMP Guide Part I, Draft Chapter 3 Premises and Equipment
    • C.4.5.1 EU-GMP Guide Part I, Draft Chapter 5 Production
    • C.4.8.1 EU-GMP Guide Part I, Draft Chapter 8 Complaints, Quality Defects and Product Recalls
    • C.6.15.1 EU-GMP Guide Part I, Draft Annex 15 Qualification and Validation
    • C.6.16.1 EU-GMP Guide Part I, Draft Annex 16 Certification by a Qualified Person and Batch Release
    • C.14.1 Good Distribution Practice for Medicinal Products for Human Use Questions and Answers
    • C.17 Guideline on Process Validation for Finished Products – Information and Data to be Provided in Regulatory Submissions
  • Chapter D CFR and FDA Guidelines
    • D.6 Pharmaceutical CGMPs for the 21st Century – A Risk Based Approach
    • D.7 General Principles of Software Validation; Final Guidance for Industry and FDA Staff

Updated Chapters:

  • Chapter C EU Directives and Guidelines
    • C.4.6 EU GMP Guide Part I, Chapter 6 Quality Control
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Wed, 11 Jun 2014 22:00:00 +0000
<![CDATA[PIC/S Committee and PIC/S Expert Circle on APIs]]> http://gmpupdate.swhosting6.de/en/gmp-news/gmp-aktuell/pics-committee-and-expert-circle-on-apis.html From 15 to 21 May 2014 the following events took place in Rome (Italy): PIC/S Committee Meeting, PIC/S Executive Bureau Meeting and PIC/S Expert Circle on Active Pharmaceutical Ingredients (APIs).

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Tue, 10 Jun 2014 22:00:00 +0000
<![CDATA[LOGFILE No. 16/2014 - EU GMP-Guide Revisions]]> http://gmpupdate.swhosting6.de/en/lead-article/gmp-aktuell/gmp-logfile-eu-gmp-guide-revisions.html How do new developments find their way into the EU GMP Guide?

What is the present status of the revision of the EU GMP Guide?

by Dr. Sabine Paris

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Tue, 03 Jun 2014 22:00:00 +0000
<![CDATA[FDA: International Operation against Online Pharmacies]]> http://gmpupdate.swhosting6.de/en/gmp-news/gmp-aktuell/fda-operation-against-online-pharmacies.html The FDA, in partnership with other federal and international agencies, took action last week against websites that sell potentially dangerous, unapproved prescription drugs to U.S. consumers. The Customs and Border Protection (CBP) also conducted extensive investigations at U.S.-based international mail facilities, where many packages containing prescription drugs enter the USA, and found that most of the packages examined contained illegal prescription drugs that had been ordered from online sources.

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Mon, 26 May 2014 22:00:00 +0000
<![CDATA[LOGFILE No. 14/2014 - Quality is more than GMP Compliance]]> http://gmpupdate.swhosting6.de/en/lead-article/gmp-aktuell/gmp-logfile-quality-is-more-than-gmp-compliance.html There's More to Quality than GMP Compliance

by Thomas Peither

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Tue, 20 May 2014 22:00:00 +0000
<![CDATA[PIC/S News]]> http://gmpupdate.swhosting6.de/en/gmp-news/gmp-aktuell/pics-gdp-korea-japan.html The PIC/S Committee has adopted a Guide on Good Distribution Practice (GDP), which will enter into force on 1st June 2014. The PIC/S GDP Guide is based on the EU GDP Guide.

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Mon, 19 May 2014 22:00:00 +0000
<![CDATA[EMA: Q&As to Herbal Medicinal Products]]> http://gmpupdate.swhosting6.de/en/gmp-news/gmp-aktuell/ema-questions-answers-herbal-products.html The EMA has published a "Questions & Answers Document on the EU framework for (traditional) herbal medicinal products, including those from a non-European tradition".

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Mon, 19 May 2014 22:00:00 +0000
<![CDATA[FDA: Drug Supply Chain Security and more]]> http://gmpupdate.swhosting6.de/en/gmp-news/gmp-aktuell/FDA-drug-supply-chain-security.html As previously reported, the FDA is working on a system that will help to identify and trace dangerous drugs that are counterfeit, stolen or tainted throughout the whole supply chain. Together with drug manufacturers, wholesaler distributors, repackers and many dispensers the FDA is working on the development of standards for this new system.

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Sun, 11 May 2014 22:00:00 +0000
<![CDATA[EMA: Draft on Process Validation of Biotechnology-derived Products]]> http://gmpupdate.swhosting6.de/en/gmp-news/gmp-aktuell/EMA-draft-biotechnology-derived-products-process-validation.html The EMA has published the “Draft guideline on process validation for the manufacture of biotechnology-derived active substances and data to be provided in the regulatory submission”.

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Tue, 06 May 2014 22:00:00 +0000
<![CDATA[CDER: Updated List of Guidance Documents]]> http://gmpupdate.swhosting6.de/en/gmp-news/gmp-aktuell/CDER-guidance-documents-list-2014.html With the beginning of this month, the FDA has published the following two updated lists of guidance documents:

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Tue, 29 Apr 2014 22:00:00 +0000
<![CDATA[LOGFILE No. 10/2014 - Preventing Cross-Contamination]]> http://gmpupdate.swhosting6.de/en/lead-article/gmp-aktuell/gmp-logfile-preventing-cross-contamination.html Preventing Cross-Contamination

by Susanne Sailer

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Tue, 22 Apr 2014 22:00:00 +0000
<![CDATA[WHO: Appendix 7: Non-sterile Process Validation]]> http://gmpupdate.swhosting6.de/en/gmp-news/gmp-aktuell/who-non-sterile-process-validation-appendix-7.html This month, the WHO has published a proposal for the revision of the supplementary guidelines on GMP: Validation, namely Appendix 7 – non-sterile process validation. A presentation to the WHO Expert Committee is planned for October 2014.

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Mon, 14 Apr 2014 22:00:00 +0000
<![CDATA[LOGFILE No. 08/2014 - Packaging Medicinal Products]]> http://gmpupdate.swhosting6.de/en/lead-article/gmp-aktuell/gmp-logfile-packaging-medicinal-products.html Packaging Medicinal Products
An excerpt from the GMP MANUAL

by Dr. Christian Gausepohl, Ruven Brandes

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Tue, 08 Apr 2014 22:00:00 +0000
<![CDATA[EU-GMP: Chapter 6 Quality Control]]> http://gmpupdate.swhosting6.de/en/gmp-news/gmp-aktuell/eu-gmp-guidelines-chapter-6-quality-control-2014.html The European Commission has published the final version of Chapter 6 Quality Control of the EU Guidelines for Good Manufacturing Practice for Medicinal Products for Human and Veterinary Use on April 3, 2014.

The revised document will enter into force on 1 October 2014 and then supersede the previous version of 2005.

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Mon, 07 Apr 2014 22:00:00 +0000
<![CDATA[EU GDP: Q&A document published]]> http://gmpupdate.swhosting6.de/en/gmp-news/gmp-aktuell/ec-gdp-question-answer-document-version-1.html On 1 April 2014, the European Commission has published a “Question and Answer” document (version 1.0, March 2014) responding to frequently asked questions in relation to the guidelines on Good Distribution Practice of medicinal products for human use.

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Sun, 06 Apr 2014 22:00:00 +0000
<![CDATA[China: Medical Equipment Safety]]> http://gmpupdate.swhosting6.de/en/gmp-news/gmp-aktuell/china-cfda-medical-equipment-safety.html According to the China Food and Drug Administration CFDA, the Chinese government on Monday unveiled a revised regulation on the supervision of medical equipment to enhance its safety and effectiveness and safeguard public health.

mehr]]>
Sun, 06 Apr 2014 22:00:00 +0000
<![CDATA[EMA: Guideline on Process Validation]]> http://gmpupdate.swhosting6.de/en/gmp-news/gmp-aktuell/ema-final-version-process-validation-2014.html The EMA has published the final version of the long awaited Guideline on Process Validation “Guideline on process validation for finished products – information and data to be provided in regulatory submissions” on February 24, 2014. It will enter into force in August 2014.

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Tue, 25 Mar 2014 23:00:00 +0000
<![CDATA[LOGFILE No. 07/2014 - How to Master Crisis Situations]]> http://gmpupdate.swhosting6.de/en/lead-article/gmp-aktuell/gmp-logfile-how-to-master-crisis-situations.html How to Master Crisis Situations

by Susanne Sailer

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Tue, 25 Mar 2014 23:00:00 +0000
<![CDATA[FDA reduces domestic GMP inspections]]> http://gmpupdate.swhosting6.de/en/gmp-news/gmp-aktuell/fda-domestic-gmp-inspection.html The FDA plans to reduce its number of routine GMP inspections in the U.S. by 40 % and thus to scale up its inspections overseas. This new strategy shall improve the quality of drugs imported into the U.S. and will bring the FDA closer to achieving its longtime goal of bringing parity to domestic and foreign inspections.

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Tue, 25 Mar 2014 23:00:00 +0000
<![CDATA[GMP MANUAL Update No. 17]]> http://gmpupdate.swhosting6.de/en/gmp-news-updates/gmp-aktuell/17-update-gmp-manual.html The content of Update No.17 is outlined below:

GMP in Practice

New Chapters:

  • 13.C Qualification of a servo-controlled blister packaging line
  • 21. Active Pharmaceutical Ingredients (completely new version)

Updated Chapters:

  • 13.B Packaging Process
  • 13.D References
  • 15.B GMP-compliant Documentation

GMP Regulations

New Chapters:

  • Chapter D: CFR and FDA Guidelines
    • D.1.5: 21 CFR Part 4 – Regulation of Combination Products
    • D.1.6: 21 CFR Part 600 – Biological Products: General
    • D.1.7: 21 CFR Part 606 – cGMP for Blood and Blood Components
  • Chapter F: PIC/S Guidelines
    • F.22: PIC/S PE 010-4 – Guide to Good Practices for the Preparation of Medicinal Products in Healthcare Establishments
    • F.23: PIC/S PI 021-2 – GMP Particularities in the Manufacture of Medicinal Products to be Used in Clinical Trials on Human Subjects

Updated Chapters:

  • Chapter C: EU Directives and Guidelines
    • C.4.2: EU GMP Guidelines, Chapter 2 Personnel
    • C.14: Guidelines on Good Distribution Practice of Medicinal Products for Human Use
  • Chapter G: GMP of other Regions
    • G.2.2.7: Canadian Regulations, Annex 14 to the Current Edition of the Good Manufacturing Practices Guidelines – Schedule D Drugs, Human Blood and Blood Components (GUI-0032)
  • Chapter H: Information
    • H.3: Addresses
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Wed, 12 Mar 2014 23:00:00 +0000
<![CDATA[FDA: Draft to Validation of Analytical Methods]]> http://gmpupdate.swhosting6.de/en/gmp-news/gmp-aktuell/fda-draft-validation-analytical-methods.html The FDA has published a Draft Guideline for Industry entitled Analytical Procedures and Methods Validation for Drugs and Biologics. The revised document supersedes a draft of the year 2000 and – once finalized – will also replace the 1987 FDA Guidance on Submitting Samples and Analytical Data for Method Validation.

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Mon, 03 Mar 2014 23:00:00 +0000
<![CDATA[Pharmacovigilance: EMA and FDA collaborate]]> http://gmpupdate.swhosting6.de/en/gmp-news/gmp-aktuell/ema-fda-pharmacovigilance-collaboration.html The European Medicines Agency (EMA) and the United States Food and Drug Administration (FDA) have set up a new 'cluster' on pharmacovigilance (medicine safety) topics.

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Mon, 03 Mar 2014 23:00:00 +0000
<![CDATA[LOGFILE No. 05/2014 - Transportation Risk Management]]> http://gmpupdate.swhosting6.de/en/lead-article/gmp-aktuell/gmp-logfile-risk-management-in-transportation.html Risk management in transportation
An excerpt from the GMP MANUAL

by Dr. Nicola Spiggelkötter, Consultant, Germany

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Tue, 25 Feb 2014 23:00:00 +0000
<![CDATA[FDA: Secure Supply Chain Pilot Program]]> http://gmpupdate.swhosting6.de/en/gmp-news/gmp-aktuell/us-fda-secure-chain-pilot-program.html The FDA initiates the Secure Supply Chain Pilot Program to enhance the security of imported drugs. So far thirteen prequalified companies have been accepted for participation and will receive expedited entry for the importation of up to five selected drug products into the United States.

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Sun, 23 Feb 2014 23:00:00 +0000
<![CDATA[CFDA: Medical Device Regulation]]> http://gmpupdate.swhosting6.de/en/gmp-news/gmp-aktuell/cfda-china-medical-device-regulation-2014.html The CFDA has announced the adoption of the draft amendment to the Regulations for the Supervision and Administration of Medical Devices at the executive meeting of the State Council on February 12, 2014. The regulations will be promulgated and implemented soon.

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Sun, 23 Feb 2014 23:00:00 +0000
<![CDATA[Swissmedic: Agreement with Korean Republic]]> http://gmpupdate.swhosting6.de/en/gmp-news/gmp-aktuell/swissmedic-agreement-korean-republic.html As announced by the Swiss Regulatory Authority Swissmedic, a Memorandum of Understanding in the area of therapeutic products was signed with the Korean Ministry for Food and Drug Safety (MFDS). This was part of a state visit of the President of the Republic of Korea.

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Wed, 19 Feb 2014 23:00:00 +0000
<![CDATA[FDA: Guidance Agenda 2014]]> http://gmpupdate.swhosting6.de/en/gmp-news/gmp-aktuell/fda-guidance-agenda.html The FDA has published its yearly guidance agenda including the new and revised draft guidances CDER is planning to publish during the calendar year 2014.

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Tue, 11 Feb 2014 23:00:00 +0000
<![CDATA[LOGFILE No. 04/2014 - Key to success in a world of failures]]> http://gmpupdate.swhosting6.de/en/lead-article/gmp-aktuell/gmp-logfile-investigations-key-to-success.html Investigation: A Key to Success in a World of Failures

by Thomas Peither, Maas & Peither AG, GMP Publishing, Germany

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Tue, 11 Feb 2014 23:00:00 +0000
<![CDATA[EC: Public Consultation on Revision of Annex 15]]> http://gmpupdate.swhosting6.de/en/gmp-news/gmp-aktuell/EC-public-consultation-revision-annex-15-qualification-validation.html Today the European Commission has launched the public consultation on the revision of Annex 15: Qualification and Validation.

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Sun, 09 Feb 2014 23:00:00 +0000
<![CDATA[EU evaluates FDA findings on Ranbaxy]]> http://gmpupdate.swhosting6.de/en/gmp-news/gmp-aktuell/EU-Ranbaxy-FDA-findings.html Shortly after the FDA notified Ranbaxy Laboratories, Ltd., that it is prohibited from manufacturing and distributing active pharmaceutical ingredients (APIs) from its facility in Toansa, India, for FDA-regulated drug products due to particularly serious GMP deficiencies, health agencies in Europe are evaluating the FDA inspection findings to assess if these deviations from GMP have any implication on medicines on the European market. Additional information requested from the marketing authorisation holders in the EU and from Ranbaxy itself will also be considered.

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Mon, 03 Feb 2014 23:00:00 +0000
<![CDATA[Revised PIC/S GMP Guide]]> http://gmpupdate.swhosting6.de/en/gmp-news/gmp-aktuell/PIC-S-gmp-guide-revised.html According to the Pharmaceutical Inspection Co-operation Scheme PIC/S, the PIC/S Committee has adopted the revision of the PIC/S GMP Guide (PE 009-11). The document will enter into force on 1 March 2014.

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Mon, 03 Feb 2014 23:00:00 +0000
<![CDATA[PIC/S: PIC/S GMP Guide for Healthcare Establishments]]> http://gmpupdate.swhosting6.de/en/gmp-news/gmp-aktuell/PIC-S-GMP-guide-healthcare-establishments.html The PIC/S Committee has adopted the revision of the PIC/S Guide to Good Practices for the Preparation of Medicinal Products in Healthcare Establishments (PE 010-4), which includes a new Annex 3 on radiopharmaceuticals.

This revised document will enter into force on 1 March 2014.

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Mon, 03 Feb 2014 23:00:00 +0000
<![CDATA[LOGFILE No. 03/2014 - GDP Audit Checklist - GMP News: GDP in India]]> http://gmpupdate.swhosting6.de/en/lead-article/gmp-aktuell/gmp-logfile-gdp-audit-checklist-warehousing.html Warehousing

An excerpt from the GDP Audit Checklist

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Tue, 28 Jan 2014 23:00:00 +0000
<![CDATA[India GDP: Sub-committee for transportation guidelines constituted]]> http://gmpupdate.swhosting6.de/en/gmp-news/gmp-aktuell/india-GDP-committee-transportation-guidelines.html The Health Ministry of India has constituted a sub-committee to prepare guidelines regulating the transportation of drugs in the country. This is a significant step as at present there are no rules or guidelines to be followed by transport agencies.

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Sun, 26 Jan 2014 23:00:00 +0000
<![CDATA[LOGFILE No. 02/2014 - Fight against counterfeit medicines - GMP News: CFDA]]> http://gmpupdate.swhosting6.de/en/lead-article/gmp-aktuell/gmp-logfile-fight-against-counterfeit-medicines.html Fight against counterfeit medicines

An excerpt from the GMP MANUAL

by Dr. Stephan Schwarze - Bayer Pharma AG, Germany

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Wed, 22 Jan 2014 23:00:00 +0000
<![CDATA[CFDA: Revised GMP for sterile pharmaceutical products]]> http://gmpupdate.swhosting6.de/en/gmp-news/gmp-aktuell/CFDA-GMP-sterile-pharmaceutical-products-china.html Early this month, the China Food and Drug Administration (CFDA) issued an announcement on the implementation of the Good Manufacturing Practice for Drugs (2010 Revision) for sterile pharmaceutical products.

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Mon, 20 Jan 2014 23:00:00 +0000
<![CDATA[LOGFILE No. 01/2014 - GMP Guidelines: What to expect 2014? - GMP News]]> http://gmpupdate.swhosting6.de/en/lead-article/gmp-aktuell/gmp-logfile-what-to-expect-2014.html GMP Guidelines: What to expect 2014?

by Anita Maas and Thomas Peither,

Maas & Peither AG - GMP Publishing

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Wed, 15 Jan 2014 23:00:00 +0000
<![CDATA[EMA: GMP non-compliance data now accessible]]> http://gmpupdate.swhosting6.de/en/gmp-news/gmp-aktuell/EMA-GMP-non-compliance-public-accessible.html As part of its transparency initiative the European Medicines Agency (EMA) has already published details of manufacturers who have violated GMP.

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Mon, 13 Jan 2014 23:00:00 +0000
<![CDATA[India considers revision of Schedule M]]> http://gmpupdate.swhosting6.de/en/gmp-news/gmp-aktuell/India-consideration-revision-schedule-M.html According to pharmabiz, the government of India is planning a revision of its GMP guidelines – Schedule M – and considers making them on par with the WHO-GMP standards. Therefore, the Drugs Controller General of India (DCGI) has asked for inputs from experts to get their GMP standards on track with global standards.

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Mon, 13 Jan 2014 23:00:00 +0000
<![CDATA[FDA and EMA launch new joint initiative]]> http://gmpupdate.swhosting6.de/en/gmp-news/gmp-aktuell/FDA-EMA-new-joint-initiative.html Late last month, the U.S. FDA and the EMA (European Medicines Agency) announced the launch of a joint initiative to share information on inspections of bioequivalence studies submitted in support of generic drug approvals. This collaborative effort provides a mechanism to conduct joint facility inspections for generic drug applications submitted to both agencies.

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Mon, 13 Jan 2014 23:00:00 +0000
<![CDATA[ICH: Future Topics]]> http://gmpupdate.swhosting6.de/en/gmp-news/gmp-aktuell/ICH-future-topics.html The International Conference on Harmonisation (ICH) Steering Committee (SC) and its Expert Working Groups (EWGs) published the results of their last meeting in Osaka: ICH Reviews Future ICH Topics and Its Organisation Towards Increased Engagement Globally. The ICH SC furthered discussions on governance and increased engagement of regulators.

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Tue, 10 Dec 2013 23:00:00 +0000
<![CDATA[EFPIA: Comments to Annex 16]]> http://gmpupdate.swhosting6.de/en/gmp-news/gmp-aktuell/EFPIA-comments-annex-16.html In June the European Commission published the changes to Annex 16 of the EU GMP Guideline. One oft the first comments was submitted by the EFPIA (European Federation of Pharmaceutical Industries and Associations): Submission of comments to Annex 16 "Certification by a Qualified Person and Batch Release".

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Tue, 10 Dec 2013 23:00:00 +0000
<![CDATA[LOGFILE No. 32/2013 - Risk Assessment for Computerized Systems - GMP News]]> http://gmpupdate.swhosting6.de/en/lead-article/gmp-aktuell/gmp-logfile-risk-management-for-cs.html Risk Management for Computerized Systems

An Excerpt from "Computer System Validation in the EU"

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Tue, 10 Dec 2013 23:00:00 +0000
<![CDATA[LOGFILE No. 31/2013 - Preparing GMP Inspections - Change in EU GDP Guideline]]> http://gmpupdate.swhosting6.de/en/lead-article/gmp-aktuell/gmp-logfile-preparing-gmp-inspections.html Preparing GMP Inspections

An Excerpt from "Preparing for the EU GMP Inspection"

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Wed, 04 Dec 2013 23:00:00 +0000
<![CDATA[New Version of EU GDP Guidelines]]> http://gmpupdate.swhosting6.de/en/gmp-news/gmp-aktuell/new-version-GDP-guidelines-EU-november-2013.html A new version of the Guidelines on Good Distribution Practice (GDP) of medicinal products was published by the European Commission.
The revised guidelines correct factual mistakes in subchapters 5.5. and 6.3., give more explanations on the rationale for the revision and provide a formal date of coming into operation. These guidelines, which replace the guidelines on GDP published in March 2013, are applicable as of 24 November 2013.

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Thu, 28 Nov 2013 23:00:00 +0000
<![CDATA[EU Guide to GMP: Responses to Public Consultations]]> http://gmpupdate.swhosting6.de/en/gmp-news/gmp-aktuell/EC-responses-public-consultation-EU-guide-to-gmp.html The European Commission has published the responses received regarding the planned revision of the following chapters of the GMP-Guidelines Part I - Basic requirements for Medicinal Products:

  • Chapter 3 Premises and Equipment
  • Chapter 5 Production
  • Chapter 6 Outsourced Activities
  • Chapter 8 Complaints and Product Recall
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Sun, 24 Nov 2013 23:00:00 +0000
<![CDATA[Harmonisation Activities of TGA and Medsafe]]> http://gmpupdate.swhosting6.de/en/gmp-news/gmp-aktuell/harmonisation-activities-TGA-medsafe.html On 13 November 2013, Australia’s Therapeutic Goods Administration (TGA) and New Zealand’s Medicines and Medical Devices Safety Authority (Medsafe) announced the next step of their joint efforts toward regulatory harmonization and the launch of a joint regulatory agency, the Australia New Zealand Therapeutic Products Agency (ANZTPA).

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Sun, 17 Nov 2013 23:00:00 +0000
<![CDATA[PIC/S Press Release]]> http://gmpupdate.swhosting6.de/en/gmp-news/gmp-aktuell/PICS-GDP-guideline-kazakhstan.html According to a press release on the PIC/S last meeting in Ottawa, Canada, a PIC/S Expert Circle on GDP has prepared a PIC/S GDP Guide which is currently under consultation within the organisation. The document will be a voluntary guidance and is based on the EU GDP Guide.

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Sun, 17 Nov 2013 23:00:00 +0000
<![CDATA[LOGFILE No. 28/2013 - Process Validation Trends - GMP News]]> http://gmpupdate.swhosting6.de/en/lead-article/gmp-aktuell/gmp-logfile-process-validation-trends.html Process Validation Trends

By Susanne Sailer

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Tue, 12 Nov 2013 23:00:00 +0000
<![CDATA[EC: Personalised Medicine]]> http://gmpupdate.swhosting6.de/en/gmp-news/gmp-aktuell/EC-FDA-personalised-medicine.html The European Commission has published a report that takes stock of the progress made in personalised medicine, and the opportunities and challenges it presents for healthcare systems.

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Mon, 11 Nov 2013 23:00:00 +0000
<![CDATA[EMA and FDA: Q&As on Quality by Design]]> http://gmpupdate.swhosting6.de/en/gmp-news/gmp-aktuell/EMA-FDA-questions-answers-quality-by-design.html The European Medicines Agency (EMA) and the US FDA have published a second joint Q&A document which provides guidance on the quality by design concept, a risk based approach to pharmaceutical development and manufacturing. It involves designing and developing pharmaceutical formulations and manufacturing processes to help ensure product quality; these concepts are described in the international guidelines ICH Q8, Q9, Q10 and Q11.

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Mon, 11 Nov 2013 23:00:00 +0000
<![CDATA[LOGFILE No. 27/2013 - Industry Perspective on Quality Agreements - GMP News]]> http://gmpupdate.swhosting6.de/en/lead-article/gmp-aktuell/gmp-logfile-quality-agreements-II.html Quality Agreements: How to build a relationship? (Part II)

By Thomas Peither

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Tue, 05 Nov 2013 23:00:00 +0000
<![CDATA[FDA: Actions on Drug Shortages]]> http://gmpupdate.swhosting6.de/en/gmp-news/gmp-aktuell/FDA-actions-drug-shortages.html The US Food and Drug Administration (FDA) has proposed a new regulation that would require pharmaceutical manufacturers to provide the agency with advance warning of impending drug shortages.

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Mon, 04 Nov 2013 23:00:00 +0000
<![CDATA[LOGFILE No. 26/2013 - Quality Risk Management - GMP News]]> http://gmpupdate.swhosting6.de/en/lead-article/gmp-aktuell/gmp-logfile-quality-risk-management.html There's More to Risk Management than Just Risk Analysis

by Susanne Sailer

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Tue, 29 Oct 2013 23:00:00 +0000
<![CDATA[MHRA: Manufacturing Specials]]> http://gmpupdate.swhosting6.de/en/gmp-news/gmp-aktuell/MHRA-questions-answers-manufacture-specials.html MHRA has developed a new guidance document for Manufacturing Specials (MS) to ensure consistency during routine Good Manufacturing Practice (GMP) inspections and to ensure MS licence holders are aware of the authorities’ expectations in this complicated area.

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Sun, 27 Oct 2013 23:00:00 +0000
<![CDATA[TGA: Pilot Program launched for Medical Devices]]> http://gmpupdate.swhosting6.de/en/gmp-news/gmp-aktuell/TGA-pilot-program-FDA-ANVISA-HC-medical-devices.html The TGA has announced the launch of the Medical Device Single Audit Program (MDSAP) from January 2014, together with Brazil's ANVISA, Health Canada, and the US Food and Drug Administration FDA, to develop a global approach to auditing and monitoring the safe manufacturing of medical devices.

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Sun, 27 Oct 2013 23:00:00 +0000
<![CDATA[LOGFILE No. 25/2013 - Excipients - Surprise FDA inspections in India]]> http://gmpupdate.swhosting6.de/en/lead-article/gmp-aktuell/gmp-logfile-excipients.html Excipients - Safety, toxicological, and precedence of use issues

by Iain Moore, Ph. D.

An excerpt from the GMP MANUAL

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Tue, 22 Oct 2013 22:00:00 +0000
<![CDATA[FDA: Surprise Inspections in India]]> http://gmpupdate.swhosting6.de/en/gmp-news/gmp-aktuell/FDA-surprise-inspections-india.html In the past nine months, the US regulator has expanded its inspection team in India from 12 to 19, and opened two more offices in Hyderabad and Mumbai, in addition to its first office in New Delhi. With 135 FDA-approved manufacturing units in India and rising compliance problems this comes as no surprise.

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Mon, 21 Oct 2013 22:00:00 +0000
<![CDATA[EMA Reveals New Structure]]> http://gmpupdate.swhosting6.de/en/gmp-news/gmp-aktuell/EMA-new-structure.html The European Medicines Agency (EMA) has announced details of its new organisational structure with the intention to better support its health mission and its role as part of the European medicines regulatory system.

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Tue, 15 Oct 2013 22:00:00 +0000
<![CDATA[EMA Publishes Minutes of Committees]]> http://gmpupdate.swhosting6.de/en/gmp-news/gmp-aktuell/EMA-minutes-scientific-committees.html On October 2, 2013, the EMA’s Management Board agreed to publish the agendas and minutes of all its scientific committees. This is part of the EMA’s approach to increasing transparency and opening up its operations.

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Tue, 15 Oct 2013 22:00:00 +0000
<![CDATA[Japan Enters Data in EudraGMDP]]> http://gmpupdate.swhosting6.de/en/gmp-news/gmp-aktuell/Japan-EU-eudragmdp.html The Japanese Ministry of Health (MHLW) and the PMDA have started entering information on good manufacturing practice (GMP) compliance related to Japanese manufacturers, upon the manufacturer's request, into the EudraGMDP database. This is the first time that information from a non-European regulator has started to be added to EudraGMDP. The initiative is expected to speed up regulatory processes and save time for importers, manufacturers and regulatory authorities.

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Tue, 15 Oct 2013 22:00:00 +0000
<![CDATA[LOGFILE No. 24/2013 - Outsourcing - Quality Agreements - GMP News]]> http://gmpupdate.swhosting6.de/en/lead-article/gmp-aktuell/gmp-logfile-quality-agreements.html Quality Agreements: How to build a relationship? (Part I)

By Thomas Peither

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Tue, 15 Oct 2013 22:00:00 +0000
<![CDATA[FDA: ANDA Submissions]]> http://gmpupdate.swhosting6.de/en/gmp-news/gmp-aktuell/FDA-ANDA-refuse-receive.html The FDA is announcing the availability of a draft guidance for industry entitled ANDA Submissions—Refuse-to-Receive Standards.” This guidance is intended to assist applicants preparing to submit to FDA abbreviated new drug applications (ANDAs) and prior approval supplements (PASs) The guidance describes what should be included in these submissions and highlights serious deficiencies that may cause FDA to refuse to receive an ANDA.

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Tue, 08 Oct 2013 22:00:00 +0000
<![CDATA[CDER: Updated Lists of Guidance Documents]]> http://gmpupdate.swhosting6.de/en/gmp-news/gmp-aktuell/CDER-list-guidance-documents-updated.html With the beginning of this month, the FDA has published the following two updated lists of GMP guidelines:

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Tue, 08 Oct 2013 22:00:00 +0000
<![CDATA[LOGFILE No. 23/2013 - GMP Audit Checklist]]> http://gmpupdate.swhosting6.de/en/lead-article/gmp-aktuell/gmp-logfile-gmp-audit-checklist.html Buildings and Infrastuctrue

an excerpt from the GMP Audit Checklist

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Tue, 08 Oct 2013 22:00:00 +0000
<![CDATA[LOGFILE No. 22/2013 - PDA/FDA Joint Conference]]> http://gmpupdate.swhosting6.de/en/lead-article/gmp-aktuell/gmp-logfile-pda-fda-joint-conference.html What is the Future Interpretation of GMPs?

By Thomas Peither

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Tue, 01 Oct 2013 22:00:00 +0000
<![CDATA[IPEC India Expected by End of Year]]> http://gmpupdate.swhosting6.de/en/gmp-news/gmp-aktuell/IPEC-india-created.html After more than a year delay, IPEC India is expected to be created by the end of the year. IPEC-Americas’ vice chair confirmed that the registration process is moving forward. Due to difficulties concerning the naming of the organization the formation could not be realized in 2012.

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Mon, 30 Sep 2013 22:00:00 +0000
<![CDATA[EU: Safety of Medical Devices]]> http://gmpupdate.swhosting6.de/en/gmp-news/gmp-aktuell/EU--safety-medical-devices.html On 24 September 2013, the European Commission adopted two measures to improve the safety of medical devices. The new rules are:

  • A Commission Implementation Regulation clarifying the criteria to be met by notified bodies, which are responsible for inspecting manufacturers of medical devices, and
  • A Recommendation clarifying the tasks these bodies have to undertake when they perform audits and assessments in the medical devices sector.
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Mon, 30 Sep 2013 22:00:00 +0000
<![CDATA[GMP MANUAL Update No. 16]]> http://gmpupdate.swhosting6.de/en/gmp-news-updates/gmp-aktuell/16-update-gmp-manual.html The recent update of the GMP MANUAL encompasses 642 pages.

The content of Update No.16 is outlined below:

GMP in Practice

New Chapters:

Updated Chapters:

  • Chapter 11.N: References
  • Chapter 19.J: References

GMP Regulations

New Chapters:

Chapter D: CFR and FDA Guidelines

Chapter F: PIC/S Guidelines

Chapter G: GMP of Other Regions

Updated Chapters:

Chapter D: CFR and FDA Guidelines

Chapter F PIC/S Guidelines

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Sat, 28 Sep 2013 22:00:00 +0000
<![CDATA[EU GMP Guide: Final Chapter 2 on Personnel]]> http://gmpupdate.swhosting6.de/en/gmp-news/gmp-aktuell/EU-gmp-guide-final-chapter-two-personnel.html The European Commission has published the final version of the revised Chapter 2 on Personnel. Changes have been made in order to integrate the principles of “Pharmaceutical Quality System” as described in the ICH Q10 tripartite guideline. Furthermore, a section on consultants has been added.

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Sun, 15 Sep 2013 22:00:00 +0000
<![CDATA[Hong Kong SAR applies for PIC/S membership]]> http://gmpupdate.swhosting6.de/en/gmp-news/gmp-aktuell/Hong-Kong-PIC-membership.html The number of PIC/S members is constantly growing. According to PIC/S, Hong Kong SAR’s Pharmacy and Poison Board has applied for PIC/S membership. Rapporteurs for this accession will be appointed at the next PIC/S Committee Meeting in Ottawa in October.

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Sun, 15 Sep 2013 22:00:00 +0000
<![CDATA[GMP MANUAL Online - Interim Development - September 2013]]> http://gmpupdate.swhosting6.de/en/gmp-news-updates/gmp-aktuell/interim-development-september2013.html Dr. Christoph Frick and Dr. Nicola Spiggelkötter have written the following new chapter to our GMP MANUAL:

GMP in Practice

  • Chapter 24 Transport (completely new version, replaces chapter 11.N Transportation)
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Thu, 12 Sep 2013 22:00:00 +0000
<![CDATA[LOGFILE No. 21/2013 - Transport of Medicinal Products]]> http://gmpupdate.swhosting6.de/en/lead-article/gmp-aktuell/gmp-logfile-transport-and-the-quality-of-drugs.html By Dr. Christoph Frick and Dr. Nicola Spiggelkötter

Here you will find answers to the following questions:

  • Why is “good distribution practice” a topic of growing importance?
  • What is meant by “supply chain integrity”?
  • Why is it so important to maintain and monitor temperature during a transport?
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Tue, 10 Sep 2013 22:00:00 +0000
<![CDATA[LOGFILE No. 20/2013 - Change Control]]> http://gmpupdate.swhosting6.de/en/lead-article/gmp-aktuell/gmp-logfile-20-2013-change-control.html Image

Author: Dr. Michael Hiob

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Tue, 27 Aug 2013 22:00:00 +0000
<![CDATA[UK transposes Falsified Medicines Directive]]> http://gmpupdate.swhosting6.de/en/gmp-news/gmp-aktuell/UK-MHRA-falsified-medicines-directive.html The Falsified Medicines Directive (FMD) has now been transposed into UK legislation and came into force on August 20, 2013. The FMD (Directive 2011/62/EU) introduces a series of measures to prevent the entry of falsified medicines and substandard raw materials into the legal supply chain, including stricter rules on the controls and inspections of producers of active pharmaceutical ingredients (APIs), intensified record-keeping requirements for wholesale distributors, and a common EU-wide logo to identify legal online pharmacies.

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Thu, 22 Aug 2013 22:00:00 +0000
<![CDATA[FDA: Supply Chain Security Program]]> http://gmpupdate.swhosting6.de/en/gmp-news/gmp-aktuell/FDA-supply-chain-security-program.html FDA is announcing the start of the Secure Supply Chain Pilot Program (SSCPP) in order to assist the Agency in its effort to prevent the importation of adulterated, misbranded, or unapproved drugs by allowing the FDA to focus its resources on imported drugs that fall outside the program and may pose risks.

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Thu, 22 Aug 2013 22:00:00 +0000
<![CDATA[WHO: Revision of GTDP Guide]]> http://gmpupdate.swhosting6.de/en/gmp-news/gmp-aktuell/WHO-revision-GTDP-guide.html The World Health Organization - supported by the IPEC Federation Member Groups - is currently in the process of revising and updating the „Good Trade and Distribution Practices for Pharmaceutical Starting Materials“ – WHO GTDP guide -  which is open for comments for a restricted audience only until September 2013.

The draft is not to be displayed on any web site and will be presented to the WHO Expert Committee during the 48th meeting in October 2013. Following adoption, the IPEC Federation will update its own guide in line with that of WHO.

Source:

WHO: Current Projects

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Thu, 22 Aug 2013 22:00:00 +0000
<![CDATA[ICH-Draft: Q3D Elemental Impurities]]> http://gmpupdate.swhosting6.de/en/gmp-news/gmp-aktuell/ICH-elemental-impurities.html The ICH Q3D Guideline for Elemental Impurities reached Step 2b of the ICH Process in July 2013 and now enters the consultation period (Step 3).

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Tue, 13 Aug 2013 22:00:00 +0000
<![CDATA[FDA: Retrospective Review of Draft Guidance Documents]]> http://gmpupdate.swhosting6.de/en/gmp-news/gmp-aktuell/FDA-retrospective-review-of-draft-guidance-documents.html The US Food and Drug Administration's (FDA) has announced an initiative in the Center for Drug Evaluation and Research (CDER) involving the review of draft guidance documents issued before 2010. The CDER plans to determine their status, and to decide whether those guidances should be withdrawn, revised, or finalized with only minor changes. The new initiative was published in the latest edition of the Federal Register.

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Thu, 08 Aug 2013 22:00:00 +0000
<![CDATA[FDA Guidance for Safety Labeling Changes]]> http://gmpupdate.swhosting6.de/en/gmp-news/gmp-aktuell/fda-guidance-for-safety-labeling-changes.html The FDA has issued a new guidance for "Safety Labeling Changes — Implementation of Section 505(o)(4) of the FD&C Act”. This section authorizes the FDA to require certain drug and biological product application holders to make safety-related labeling changes based on new safety information that becomes available after approval of the drug or biological product.

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Sun, 04 Aug 2013 22:00:00 +0000
<![CDATA[TGA international engagement strategy 2013-2015]]> http://gmpupdate.swhosting6.de/en/gmp-news/gmp-aktuell/tga-international-engagement-strategy-2013-2015.html The Australian Therapeutic Goods Administration (TGA), part of the Department of Health and Ageing, has published an outline of its international engagement strategy for the next three years. It links current Australian government priorities for international engagement that are necessary to support effective therapeutic goods regulation with the TGA's business-as-usual activities and sets clear goals for international engagement activities.

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Sun, 04 Aug 2013 22:00:00 +0000
<![CDATA[FDA: Draft for Cosmetic GMP]]> http://gmpupdate.swhosting6.de/en/gmp-news/gmp-aktuell/FDA-draft-cosmetic-gmp.html The FDA published a draft on “Cosmetic Good Manufacturing Practices” in order to assist industry and stakeholders to identify the standards and issues that can affect the quality of cosmetic products. The document revises the “Cosmetic Good Manufacturing (GMP) Guidelines/Inspection Checklist” by updating it to set forth current practice and clarify certain topic areas based on recent experience.

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Wed, 31 Jul 2013 22:00:00 +0000
<![CDATA[LOGFILE No. 18/2013 - Audit Procedures]]> http://gmpupdate.swhosting6.de/en/lead-article/gmp-aktuell/gmp-logfile-18-2013-audit-procedures.html Image Image

Authors: Dr. Michael Hiob, Max Lazar

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Wed, 31 Jul 2013 22:00:00 +0000
<![CDATA[EU-GMP: Draft of Annex 16]]> http://gmpupdate.swhosting6.de/en/gmp-news/gmp-aktuell/EU-gmp-annex-16-draft.html The European Commission has published a draft of Annex 16 “Certification by a Qualified Person and Batch Release” of the EU GMP Guidelines. The Annex has been revised to reflect the globalisation of the pharmaceutical supply chains and the introduction of new quality control strategies. Furthermore, the ICH documents Q8, Q9 and Q10 were implemented.

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Tue, 30 Jul 2013 22:00:00 +0000
<![CDATA[FDA Finalizes Heparin Quality Monitoring Guidance]]> http://gmpupdate.swhosting6.de/en/gmp-news/gmp-aktuell/FDA-final-crude-heparin-quality-guidance.html FDA is announcing the availability of a guidance for industry entitled Heparin for Drug and Medical Device Use Monitoring Crude Heparin for Quality“. The need for the guidance can be traced back to 2007 and 2008, when heparin sourced from Chinese manufacturers killed 149 US citizens.

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Tue, 09 Jul 2013 22:00:00 +0000
<![CDATA[Mexico updates GMP for APIs]]> http://gmpupdate.swhosting6.de/en/gmp-news/gmp-aktuell/api-Mexico-update-gmp-requirements.html COFEPRIS, Mexico’s Ministry of Health, through the Federal Commission for Protection against Health Risks has updated the requirements on GMP for active pharmaceutical ingredients comparable to those of the European Union. The new GMP requirements enter into force immediately and are mandatory for all establishments engaged in the manufacture and distribution of APIs.

With this standard, Mexico believes to have met the requirement for API exports to the EU under the EU Falsified Medicines Directive, which came into force on 2 July 2013.

So far, COFEPRIS has published a Spanish version of the document..

Source:

RAPS: News

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Tue, 09 Jul 2013 22:00:00 +0000
<![CDATA[LOGFILE No. 17/2013 - Process Validation]]> http://gmpupdate.swhosting6.de/en/lead-article/gmp-aktuell/gmp-logfile-17-2013-process-validation.html Process Validation
PDA Technical Report No. 60 as a practical guideline

By Thomas Peither

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Tue, 09 Jul 2013 22:00:00 +0000
<![CDATA[WHO: New Annex 2 on Quality Risk Management]]> http://gmpupdate.swhosting6.de/en/gmp-news/gmp-aktuell/WHO-annex-two-qrm-quality-risk-management.html The WHO Expert Committee on Specifications for Pharmaceutical Preparations has published the Technical Report 981 which includes Annex 2, the WHO guidelines on quality risk management. QRM is the overall and continuing process of appropriately managing risks to product quality throughout the product's life-cycle in order to optimize its benefit–risk balance. It is a systematic process for the assessment, control, communication and review of risks to the quality of the medicinal product. It can be applied both proactively and retrospectively.

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Tue, 25 Jun 2013 22:00:00 +0000
<![CDATA[USA on EC List of Third Countries]]> http://gmpupdate.swhosting6.de/en/gmp-news/gmp-aktuell/USA-list-third-countries-written-confirmation.html The U.S. Food and Drug Administration has announced that the USA is now a “listed country” with the European Commission (EC) so that U.S. companies need not obtain an export certificate form the FDA before shipping certain pharmaceutical products to Europe.

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Tue, 25 Jun 2013 22:00:00 +0000
<![CDATA[TGA: Revised GMP-Code for Human Blood]]> http://gmpupdate.swhosting6.de/en/gmp-news/gmp-aktuell/TGA-GMP-human-blood.html As announced by the TGA, the revised “Australian code of Good Manufacturing Practice for human blood and blood components, human tissues and human cellular therapy products 2013” is now published.

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Sun, 16 Jun 2013 22:00:00 +0000
<![CDATA[List of Third Countries: Japan added]]> http://gmpupdate.swhosting6.de/en/gmp-news/gmp-aktuell/List-of-Third-Countries-Japan-API.html Japan has been added to the "list of third countries" as regards standards of manufacture and supervision of active pharmaceutical ingredients equivalent to those of the EU.

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Sun, 16 Jun 2013 22:00:00 +0000
<![CDATA[TGA: Adoption of EU/ICH guidelines]]> http://gmpupdate.swhosting6.de/en/gmp-news/gmp-aktuell/TGA-adoption-EU-ICH-guidelines.html Following consultation with relevant industry groups, TGA, the Australian Therapeutic Goods Administration, has announced the adoption of a number of EU/ICH guidelines in Australia, effective 1 June 2013.

These include, inter alia:

  • Guideline on plasma-derived medicinal products (EMA)
  • Guideline on active substance master file procedure (EMA)
  • Guideline on bioanalytical method validation (EMA)
  • Impurities: Guideline for residual solvents ICHQ3C(R5)
Source:

TGA: Newsroom

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Tue, 11 Jun 2013 22:00:00 +0000
<![CDATA[LOGFILE No. 15/2013 - Drugmakers and Contractors]]> http://gmpupdate.swhosting6.de/en/lead-article/gmp-aktuell/gmp-logfile-15-2013-relation-between-drugmaker-and-contratcor.html Relation between Drugmaker and Contractor

Extract from “Managing Contract Manufacturers and Testing Labs

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Tue, 04 Jun 2013 22:00:00 +0000
<![CDATA[FDA: Contract Manufacturing Quality Agreements]]> http://gmpupdate.swhosting6.de/en/gmp-news/gmp-aktuell/FDA-contract-manufacturing-quality-agreements.html On 24 May 2013, the FDA has published a draft guidance for industry entitled “Contract Manufacturing Arrangements for Drugs: Quality Agreements”. The guidance describes the current thinking of the government authority on defining, establishing and documenting the responsibilities of all parties involved in the contract manufacturing of drugs subject to Current Good Manufacturing Practice (CGMP).

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Tue, 04 Jun 2013 22:00:00 +0000
<![CDATA[CFDA: Relevant issues on Written Confirmation]]> http://gmpupdate.swhosting6.de/en/gmp-news/gmp-aktuell/CFDA-written-confirmation-API.html The Chinese Authorities have recently released a few newslets, one concerning the “Written Confirmation for active substances exported to the EU”, an omnipresent topic.

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Tue, 04 Jun 2013 22:00:00 +0000
<![CDATA[China: SFDA becomes CFDA]]> http://gmpupdate.swhosting6.de/en/gmp-news/gmp-aktuell/China-SFDA-CFDA.html China’s State Food and Drug Administration (SFDA) is now under new leadership and has changed its name to "The China Food and Drug Administration – CFDA".

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Tue, 04 Jun 2013 22:00:00 +0000
<![CDATA[Health Canada: GMP for all APIs]]> http://gmpupdate.swhosting6.de/en/gmp-news/gmp-aktuell/gmp-health-canada-api.html As announced by Health Canada last week, Harper Government plans on strengthening drug safety with new standards, as Good Manufacturing Practices now apply to all active pharmaceutical ingredients

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Tue, 28 May 2013 22:00:00 +0000
<![CDATA[LOGFILE No. 14/2013 - GMP Validation Documentation]]> http://gmpupdate.swhosting6.de/en/lead-article/gmp-aktuell/gmp-logfile-14-2013-documenting-process-validation-introduction.html Documenting Process Validation: Introduction

Extract from “Documenting Process Validation: A Drugmaker’s Guide”

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Tue, 28 May 2013 22:00:00 +0000
<![CDATA[WHO: Draft of GMP-Validation, Appendix 7]]> http://gmpupdate.swhosting6.de/en/gmp-news/gmp-aktuell/WHO-draft-guideline-validation-appendix-seven.html The WHO has published a proposal for revision of the Supplementary Guidelines on GMP: Validation, Appendix 7: Non-sterile Process Validation in April 2013. The revised document is expected for October 2013, after its presentation to the WHO Expert Committee on Specifications for Pharmaceutical Preparations.

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Mon, 27 May 2013 22:00:00 +0000
<![CDATA[EMA: Reorganisation]]> http://gmpupdate.swhosting6.de/en/gmp-news/gmp-aktuell/EMA-reorganisation.html The European Medicines Agency (EMA) has announced the first details of its planned reorganisation. Rooted firmly in the Agency’s overall public and animal health mission, the changes reflect a renewed focus on three key elements:

  • how to better support the scientific work of the EMA committees,
  • how to better share the data the Agency holds and
  • how to better meet the needs of its stakeholders and partners.
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Tue, 14 May 2013 22:00:00 +0000
<![CDATA[LOGFILE No. 12/2013 - The Brazilian GMP Guideline]]> http://gmpupdate.swhosting6.de/en/lead-article/gmp-aktuell/gmp-logfile-12-2013-brazilian-gmp-guidelines.html The Brazilian GMP Guideline

By Dr. Hans H. Schicht

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Tue, 07 May 2013 22:00:00 +0000
<![CDATA[EMA: Draft Guideline on Biosimilars]]> http://gmpupdate.swhosting6.de/en/gmp-news/gmp-aktuell/ema-draft-guideline-biosimilars.html The EMA has published a draft guideline on similar biological medicinal products on May 2, 2013, which is now open for public consultation.

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Sun, 05 May 2013 22:00:00 +0000
<![CDATA[Australia added to „list of third countries“]]> http://gmpupdate.swhosting6.de/en/gmp-news/gmp-aktuell/australia-added-list-third-countries-written-confirmation.html Australia has been added to the "list of third countries" as regards standards of manufacture and supervision of active pharmaceutical ingredients equivalent to those of the EU. Following Switzerland, Australia is the second country to be adopted and listed by the European Commission.

Source:

EC: Commission implementing decision

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Mon, 29 Apr 2013 22:00:00 +0000
<![CDATA[EMA: New Eudra GMDP database]]> http://gmpupdate.swhosting6.de/en/gmp-news/gmp-aktuell/ema-new-eudra-gmdp-database.html The European Medicines Agency (EMA) has upgraded its EudraGMP database so that it now contains information on good distribution practice (GDP) in addition to good manufacturing practice (GMP). The new database is a key deliverable of the new European Falsified Medicines Directive and will make the supervision of manufacturing and distribution of medicines more robust by allowing all the actors in the supply chain to check information available on their suppliers.

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Mon, 29 Apr 2013 22:00:00 +0000
<![CDATA[LOGFILE No. 10/2013 - Deviations - GMPnews FDA, India and EU]]> http://gmpupdate.swhosting6.de/en/lead-article/gmp-aktuell/gmp-logfile-10-2013-deviations-gmpnews-fda-india-and-eu.html Deviations – Definition and Requirements

By Dr. Christian Gausepohl

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Tue, 23 Apr 2013 22:00:00 +0000
<![CDATA[India: Draft Guidelines for Export of APIs to EU]]> http://gmpupdate.swhosting6.de/en/gmp-news/gmp-aktuell/india-draft-guideline-API-export-EU.html India has recently published the revised draft guidelines for the issue of the “Written Confirmation” for APIs exported to the EU in accordance with Article 46(2)(b) of Directives No. 2001/83/EC.

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Tue, 16 Apr 2013 22:00:00 +0000
<![CDATA[FDA: CSV in Blood Establishments]]> http://gmpupdate.swhosting6.de/en/gmp-news/gmp-aktuell/FDA-computer-system-validation-blood-establishment.html This month the FDA has published the final version of the Guidance for Industry "Blood Establishment Computer System Validation in the User´s Facility". The FDA issued this guidance to assist blood establishments in developing a blood establishment computer system validation program, consistent with recognized principles of software validation, quality assurance, and current good software engineering practices.

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Tue, 16 Apr 2013 22:00:00 +0000
<![CDATA[EC: Q&A document 4.1 to Written Confirmation]]> http://gmpupdate.swhosting6.de/en/gmp-news/gmp-aktuell/EC-new-version-4.1--questions-answers-written-confirmation.html On 16 April 2013 the European Commission published Version 4.1 of the Q&A document regarding the importation of APIs to the EU. This version contains two new questions (2A and 10A) and their corresponding answers. Question 11B on atypical active substances –which was only added last week - has been removed as additional discussions with Member States are needed.

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Tue, 16 Apr 2013 22:00:00 +0000
<![CDATA[GMP MANUAL Update No. 15]]> http://gmpupdate.swhosting6.de/en/gmp-news-updates/gmp-aktuell/15-update-gmp-manual-april.html The recent update of the GMP MANUAL (April 2013)c encompasses approx. 650 pages. The contents of Update No.15 are outlined below:

“GMP in Practice”

New Chapters:

  • 15: Documentation
    • 15.F: Electronic Batch Recording and Batch Release (replaces 15.C.3)
    • 15.G: Document Management Systems
  • 19: Quality Unit
    • 19.E: Deviations (replaces 11.K)
    • 19.H: Complaints and Recalls

Updated Chapters:

  • 19: Quality Unit
    • 19.F: Batch Record Review (formerly 15.C.5)
    • 19.G: Product Quality Review and Annual Product Review (formerly 15.F)
  • Chapter 22: Excipients (formerly 21.C)

“GMP Regulations”

New Chapters:

  • B: National Bodies and Pharmaceutical Associations
  • C: EU Directives and Guidelines
    • C.8.5: Template for the “written confirmation” for active substances exported to the European Union for medicinal products for human use
    • C.8.5.1: Importation of Active Substances for Medicinal Products for Human Use; Questions and Answers
    • C.14: Guidelines on Good Distribution Practice of Medicinal Products for Human Use
  • E: ICH Guidelines
    • E.10.2: ICH Quality Implementation Working Group: Points to Consider (R2); ICH-Endorsed Guide for ICH Q8/Q9/Q10 Implementation
    • E.11: ICH Q11: Development and Manufacture of Drug Substances (Chemical Entities and Biotechnological/Biological Entities)
  • F: PIC/S Guidelines Chapter F.13: PIC/S PI 037-1 Recommendation: A Recommended Model for Risk-based Inspection Planning in the GMP Environment
    • F.14: PIC/S PI 038-1 Aide-mémoire: Assessment Of Quality Risk Management Implementation
    • F.15: Questions & Answers Document regarding Distribution Activities for Active Pharmaceutical Ingredients (APIs) Chapter F.16: PIC/S PI 030-1 Aide-mémoire: Inspection of Active Pharmaceutical Ingredients

Updated Chapters:

  • E: ICH Guidelines
    • E.10.1: Quality Implementation Working Group on Q8, Q9 and Q10: Questions & Answers (R4)
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Mon, 01 Apr 2013 22:00:00 +0000
<![CDATA[EMA and Canada Renew Arrangement]]> http://gmpupdate.swhosting6.de/en/gmp-news/gmp-aktuell/EMA-Canada-arrangement.html The European Medicines Agency and the European Commission have renewed their confidentiality arrangement with Health Canada, the Canadian regulatory authority for medicines, for a further five-year period.

The regulatory authorities will continue their successful cooperation and further extend the exchange of information.

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Tue, 26 Mar 2013 23:00:00 +0000
<![CDATA[LOGFILE No. 09/2013 - An Introduction to PQR and APR]]> http://gmpupdate.swhosting6.de/en/lead-article/gmp-aktuell/gmp-logfile-09-2013-pqr-apr-introduction.html Product Quality Review and Annual Product Review

By Dr. Christian Gausepohl

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Tue, 26 Mar 2013 23:00:00 +0000
<![CDATA[SFDA: Revised Good Supply Practice]]> http://gmpupdate.swhosting6.de/en/gmp-news/gmp-aktuell/SFDA-good-supply-practice.html As previously announced by the SFDA, the newly revised "Good Supply Practice for Pharmaceutical Products (GSP)" was recently adopted by the Ministry of Health. It will enter into force on June 1, 2013.

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Tue, 12 Mar 2013 23:00:00 +0000
<![CDATA[New EU GDP Guideline published]]> http://gmpupdate.swhosting6.de/en/gmp-news/gmp-aktuell/new-gdp-guideline-2013-published.html The new GDP Guideline "Guideline on Good Distribution Practice of Medicinal Products for Human Use (2013/C68/01)" has been published on March 8, 2013 in the Official Journal of the European Union. It lays down appropriate tools to assist wholesale distributors in conducting their activities and to prevent falsified medicines from entering the legal supply chain and is of utmost importance for the international pharmaceutical logistic business.

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Sun, 10 Mar 2013 23:00:00 +0000
<![CDATA[LOGFILE No. 7/2013 - GMP-relevant Documents]]> http://gmpupdate.swhosting6.de/en/lead-article/gmp-aktuell/gmp-logfile-7-2013-gmp-relevant-documents.html GMP-relevant Documents

By Dr. Michael Hiob

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Tue, 26 Feb 2013 23:00:00 +0000
<![CDATA[PDA: TR on Process Validation published]]> http://gmpupdate.swhosting6.de/en/gmp-news/gmp-aktuell/PDA-technical report-process-validation.html As expected for some time, PDA has now published its "Technical Report No. 60: Process Validation – A Lifecycle Approach". According to PDA, the report presents timely and real world guidance for the application of a lifecycle approach to process validation.

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Mon, 25 Feb 2013 23:00:00 +0000
<![CDATA[FDA: Guidance Agenda for 2013]]> http://gmpupdate.swhosting6.de/en/gmp-news/gmp-aktuell/FDA-guidance-agenda-2013.html The FDA has recently published a Guidance Agenda which includes all guidances CDER is planning to publish during the calendar year 2013.

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Sun, 24 Feb 2013 23:00:00 +0000
<![CDATA[EMA/EC: Renewal of Arrangement with Japan]]> http://gmpupdate.swhosting6.de/en/gmp-news/gmp-aktuell/EMA-japan.html The European Medicines Agency (EMA) and the European Commission’s Directorate General for Health and Consumers have renewed their confidentiality arrangement with the Japanese medicines regulatory authorities for a further 5-year period.

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Tue, 19 Feb 2013 23:00:00 +0000
<![CDATA[New draft guidelines submitted by the EC]]> http://gmpupdate.swhosting6.de/en/gmp-news/gmp-aktuell/new-draft-guideline-EC.html The European Commission has submitted the following three drafts for public consultation:

  • Guidelines on the formalised risk assessment for ascertaining the appropriate good manufacturing practice for excipients of medicinal products for human use
  • Guidelines on the principles of good distribution practices for active substances for medicinal products for human use
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Tue, 19 Feb 2013 23:00:00 +0000
<![CDATA[LOGFILE No. 5/2013 - Coding and Serialisation]]> http://gmpupdate.swhosting6.de/en/lead-article/gmp-aktuell/gmp-logfile-5-2013-coding-serialisation-.html Coding and Serialisation of Folding Cardboard Boxes in the Pharmaceutical Industry

By Roland Kleissendorf

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Tue, 05 Feb 2013 23:00:00 +0000
<![CDATA[WHO: Proposed Text for GMP Annex 3]]> http://gmpupdate.swhosting6.de/en/gmp-news/gmp-aktuell/WHO-GMP-annex-3.html The WHO has published a proposed updated text for “WHO GMP for pharmaceutical products: main principles”, in January 2013. The main principles are published as Annex 3 in the WHO Technical Report Series, No. 961.

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Thu, 31 Jan 2013 23:00:00 +0000
<![CDATA[LOGFILE No. 4/2013 - EU GMP Guidelines 2013]]> http://gmpupdate.swhosting6.de/en/lead-article/gmp-aktuell/gmp-logfile-4-2013-eu-gmp-guidelines-2013.html Which European Guidelines will change in 2013?

By Thomas Peither, Maas & Peither AG - GMP Publishing

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Tue, 29 Jan 2013 23:00:00 +0000
<![CDATA[EC: Import of APIs]]> http://gmpupdate.swhosting6.de/en/gmp-news/gmp-aktuell/EC-import-APIs-active-pharmaceutical-ingredients-GMP.html The European Commission submitted a draft of Version2.0 „Template for the written confirmation for active substances exported to the European Union for medicinal products for human use, in accordance with Article 46b(2)(b) of Directive 2001/83/EC“ to the Pharmaceutical Committee.

Along with the template, a draft of Version 3.0 of the corresponding Q&A document was submitted to the Committee, as well.

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Tue, 29 Jan 2013 23:00:00 +0000
<![CDATA[EU: ACAA with Israel]]> http://gmpupdate.swhosting6.de/en/gmp-news/gmp-aktuell/EU-ACAA-israel.html On January 19, 2013, the European Commission has put in place a legal framework for a close collaboration between the European Union and Israel.

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Tue, 29 Jan 2013 23:00:00 +0000
<![CDATA[LOGFILE No. 3/2013 - Improve Quality Systems - Part II]]> http://gmpupdate.swhosting6.de/en/lead-article/gmp-aktuell/gmp-logfile-3-2013-improving-quality-systems-part2.html Simplification Can Improve Quality Systems, Experts Say
Part II

Rebecca Stauffer, PDA

This article was first published in the Nov/Dec 2012 PDA Letter.
Reprinted with permission of PDA, Inc.

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Tue, 22 Jan 2013 23:00:00 +0000
<![CDATA[EC: Revision of GMP Guidelines]]> http://gmpupdate.swhosting6.de/en/gmp-news/gmp-aktuell/EC-revision-eu-gmp-guidelines.html On January 17, 2013 the European Commission launched the public consultation of the following revised GMP guidelines:

  • Chapter 3: Premises and Equipment
  • Chapter 5: Production
  • Chapter 6: Quality Control
  • Chapter 8: Complaints, Quality Defects and Product Recalls.
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Tue, 22 Jan 2013 23:00:00 +0000
<![CDATA[FDA: Facility Fees 2013 (GDUFA)]]> http://gmpupdate.swhosting6.de/en/gmp-news/gmp-aktuell/FDA-facility-fees-2013-GDUFA.html On January 16, 2013, the FDA published a Federal Register notice setting fiscal year (FY) 2013 fee rates for generic drug active pharmaceutical ingredient (API) and finished dosage form (FDF) facilities as required by the Generic Drug User Fee Amendments (GDUFA) of 2012.

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Mon, 21 Jan 2013 23:00:00 +0000
<![CDATA[LOGFILE No. 2/2013 - Improve Quality Systems]]> http://gmpupdate.swhosting6.de/en/lead-article/gmp-aktuell/gmp-logfile-2-2013-improve-pharma-quality-systems.html Simplification Can Improve Quality Systems, Experts Say
Part I

Rebecca Stauffer, PDA

This article was first published in the Nov/Dec 2012 PDA Letter.
Reprinted with permission of PDA, Inc.

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Tue, 15 Jan 2013 23:00:00 +0000
<![CDATA[EMA: Risk Identification (Draft Guideline)]]> http://gmpupdate.swhosting6.de/en/gmp-news/gmp-aktuell/EMA-draft-risk-identification.html On January 8, 2013 the EMA has published a "Draft guideline on setting health based exposure limits for use in risk identification in the manufacture of different medicinal products in shared facilities".

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Sun, 13 Jan 2013 23:00:00 +0000
<![CDATA[LOGFILE No. 1/2013 - Pharmaceutical Microbiology Labs]]> http://gmpupdate.swhosting6.de/en/lead-article/gmp-aktuell/gmp-logfile-feature-1-2013-good-practices-pharma-micro-labs.html Good practices for Pharmaceutical Microbiology Laboratories
A review of the WHO Guidance

by Tim Sandle

This article is republished with permission from GMP REVIEW, VOL.11 NO.3 OCTOBER 2012.

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Tue, 08 Jan 2013 23:00:00 +0000
<![CDATA[PIC/S: GMP Guide revised]]> http://gmpupdate.swhosting6.de/en/gmp-news/gmp-aktuell/PIC-S-gmp-guide-revised-pe-009-10.html The PIC/S has published its revised GMP Guide (PE 009-10) in December. The amendments relate to Chapter 4 (Part I, Documentation) and Annexes 6 (Medicinal Gases), 7 (Herbal Medicinal Products), 11 (Computerized Systems) and 13 (Investigational Medicinal Products).

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Mon, 07 Jan 2013 23:00:00 +0000
<![CDATA[India: Guideline on Recall and Rapid Alert System]]> http://gmpupdate.swhosting6.de/en/gmp-news/gmp-aktuell/india-guideline-recall-rapid-alert.html As required for NRA assessment by WHO, the Indian Ministry of Health CDSCO has now published the “Guidelines on Recall and Rapid Alert System for Drugs (Including Biological and Vaccines)”.

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Sun, 16 Dec 2012 23:00:00 +0000
<![CDATA[SFDA: NIFDC Added to WHO List]]> http://gmpupdate.swhosting6.de/en/gmp-news/gmp-aktuell/SFDA-NIFDC-WHO-list.html According to SFDA News, the WHO has newly added the National Institute for Food and Drug Control (NIFDC) of China to the List of Prequalified Quality Control Laboratories.

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Sun, 16 Dec 2012 23:00:00 +0000
<![CDATA[FDA: Questions and Answers to PET Drugs]]> http://gmpupdate.swhosting6.de/en/gmp-news/gmp-aktuell/FDA-questions-answers-PET-drugs.html The PET Drugs Working Group has prepared a Question and Answer Document "FDA oversight of PET Drug Products". The final guidance was published on December 3, 2012.

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Thu, 13 Dec 2012 23:00:00 +0000
<![CDATA[EU-GMP Annex 17 Draft Concept Paper]]> http://gmpupdate.swhosting6.de/en/gmp-news/gmp-aktuell/EU-GMP-Guide-EMA-concept-paper-annex-17.html The European Medicines Agency (EMA) has published a draft concept paper on the revision of Annex 17 of the EU Guide to GMP.

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Sun, 02 Dec 2012 23:00:00 +0000
<![CDATA[EU-GMP Guide: Annex 15 Draft Concept Paper]]> http://gmpupdate.swhosting6.de/en/gmp-news/gmp-aktuell/EMA-concept-paper-annex-15.html The European Medicines Agency (EMA) has published a draft concept paper on the revision of Annex 15 "Qualification and Validation" of the EU-GMP-Guide in order to reflect the changed manufacturing and regulatory environment.

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Sun, 02 Dec 2012 23:00:00 +0000
<![CDATA[EC: Switzerland first on “third country list”]]> http://gmpupdate.swhosting6.de/en/gmp-news/gmp-aktuell/EC-switzerland-third-country-list.html Switzerland has been listed as the first third country with standards in the manufacture of active pharmaceutical ingredients equivalent to those of the EU.

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Wed, 28 Nov 2012 23:00:00 +0000
<![CDATA[ICH: Final Concept Paper on ICH Q7 Q&A]]> http://gmpupdate.swhosting6.de/en/gmp-news/gmp-aktuell/ICH-concept-paper-Q7.html The International Committee for Harmonisation ICH has published a final concept paper on ICH Q7 Q&As regarding the Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients on October 17, 2012. An Implementation Working Group (Q7 IWG) on Q7 (Q&A document) was endorsed by the Steering Committee.

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Tue, 27 Nov 2012 23:00:00 +0000
<![CDATA[HC: Risk Classification of GMP deficiencies]]> http://gmpupdate.swhosting6.de/en/gmp-news/gmp-aktuell/health-canada-risk-classification-gmp-practices-deficiencies-observations.html Health Canada has revised its Guidance GUI-0023 “Risk Classification of Good Manufacturing Practices (GMP) Observations" in order to classify observations noted during establishment inspections according to their risk.

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Tue, 20 Nov 2012 23:00:00 +0000
<![CDATA[WHO: Pharmaceutical Water Revision of Annex 3]]> http://gmpupdate.swhosting6.de/en/gmp-news/gmp-aktuell/who-revision-annex3-pharmaceutical-water.html The WHO has revised Annex 3, WHO Technical Report Series 929 – WHO Good Manufacturing Practices: Water for Pharmaceutical Use, which is now listed as Annex 2 of the current Technical Report Series 970, 2012.

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Tue, 13 Nov 2012 23:00:00 +0000
<![CDATA[LOGFILE No. 33/2012 - Biological Active Substances]]> http://gmpupdate.swhosting6.de/en/lead-article/gmp-aktuell/gmp-logfile-33-2012-biological-active-substances.html Comparison of Different Versions of Annex 2 EU Guide to GMP Part I

Maas & Peither AG - GMP Publishing (November 2012)

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Tue, 13 Nov 2012 23:00:00 +0000
<![CDATA[EC: Import of APIs - Q&A Document, Version 2.0]]> http://gmpupdate.swhosting6.de/en/gmp-news/gmp-aktuell/ec-eu-2-version-qa-document-importation-active-substances.html Shortly after publishing Version 1.0. in July 2012, the European Commission has now published a second version of the Q&A document “Importation of Active Substances for Medicinal Products for Human Use – Questions and Answers”. Four additional questions and their corresponding answers have been added.

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Mon, 12 Nov 2012 23:00:00 +0000
<![CDATA[LOGFILE No. 32/2012 - Change Management]]> http://gmpupdate.swhosting6.de/en/lead-article/gmp-aktuell/gmp-logfile-priciples-of-change-control.html Principles of Change Control

Author: Michael Hiob, Ph.D., Germany

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Tue, 06 Nov 2012 23:00:00 +0000
<![CDATA[India: Final Guideline on GDP for Biological Products]]> http://gmpupdate.swhosting6.de/en/gmp-news/gmp-aktuell/India-gdp-guideline-biological-products.html The Central Drugs Standard Control Organization (CDSCO) of India, has now published the Guidelines on Good Distribution Practices (GDP) for Biological Products, only shortly after publishing the draft guideline.

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Tue, 30 Oct 2012 23:00:00 +0000
<![CDATA[Health Canada: Draft Guidance on GMP for APIs]]> http://gmpupdate.swhosting6.de/en/gmp-news/gmp-aktuell/Health-Canada-draft-guidance-gmp-api.html Health Canada has opened a consulation period for the Draft Guidance on Good Manufacturing Practices (GMP) for Active Pharmaceutical Ingredients (APIs) Guidelines (GUI-0104).

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Mon, 29 Oct 2012 23:00:00 +0000
<![CDATA[MHRA: Public consulation on Falsified Medicine Directive]]> http://gmpupdate.swhosting6.de/en/gmp-news/gmp-aktuell/MHRA-consulation-falsified-medicine-directive.html The Falsified Medicines Directive (Directive 2011/62) substantially changes the European framework concerned with the supply of medicines, and may capture businesses that have traditionally not been directly regulated as it introduces various measures to prevent the entry of falsified medicines into the legal supply chain.

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Sun, 28 Oct 2012 23:00:00 +0000
<![CDATA[WHO: QRM Guideline Revised Draft ]]> http://gmpupdate.swhosting6.de/en/gmp-news/gmp-aktuell/WHO-revised-guideline-quality-risk-management.html The WHO has published the revised draft of the “WHO Guideline on Quality Risk Management” for commentation. The 27-pages document has been restructured based on comments and advice received prior to and during consultation and intends to cover the full scope of pharmaceutical industry QRM effectively.

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Mon, 22 Oct 2012 22:00:00 +0000
<![CDATA[EMA: Additional Guidance on ASMF]]> http://gmpupdate.swhosting6.de/en/gmp-news/gmp-aktuell/EMA-additional-guidance-active-site-master-file.html The European Medicines Agency has published an additional guidance for ASMF holders supplementary to the “Guideline on Active Substance Master File Procedure” which came into force on 1 October 2012. The document „Additonal guidance on documents relating to an active substance master file“ is intended to assist on completing Annex 2 “Letter of Access”, Annex 3 “Submission Letter” and Annex 4 “Withdrawal of Access Letter” and should be read in conjunction with the guideline.

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Sun, 21 Oct 2012 22:00:00 +0000
<![CDATA[FDA: Generic Drug User Fee Amendments 2012]]> http://gmpupdate.swhosting6.de/en/gmp-news/gmp-aktuell/FDA-generic-drug-user-fee-amendments.html As of October 1, 2012, all firms that manufacture human generic drugs will need to pay user fees to FDA. User fees are fees paid by industry to FDA to help FDA review manufacturers’ products in a timely manner. FDA has issued a number of documents to answer anticipated questions from industry about the program’s requirements and details regarding implementation. These documents also highlight preparatory steps human generic drug manufacturers will need to complete to be in compliance with this new legislation.

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Thu, 11 Oct 2012 22:00:00 +0000
<![CDATA[GMP MANUAL Update No. 14]]> http://gmpupdate.swhosting6.de/en/gmp-news-updates/gmp-aktuell/14-update-gmp-manual-november.html The recent update of the GMP MANUAL (October 2012) encompasses approx. 860 pages for the print version and 50 additional pages for the CD and online versions.

The contents of Update 14 are outlined below:

“GMP in Practice"

New Chapters:

  • Chapter 12: Sterile Production
    • 12.H Testing for Endotoxins
  • Chapter 19: Quality Unit
    • 19.D Corrective and preventive actions (CAPA)

Updated Chapters:

  • Chapter 12: Sterile Production
    • 12.F: Freeze drying / Lyophilization (formerly 12.J)
    • 12.G: Testing for sterility (formerly 12.H)
    • 12.I: Testing for tightness and particles
    • 12.J: Microbiological monitoring (formerly 12.G)
    • 12.K: References
  • Chapter 15: Documentation
    • 15.A: Official requirements
    • 15.G: References
  • Chapter 18: Inspections
    • 18.H: Questionnaire for preparing GMP-inspections
  • Chapter 19: Quality Unit
    • 19.C: Change Management (formerly Change Control)
    • 19.E: References (formerly 19.D)

“GMP Regulations”

New Chapters:

  • Chapter C: EU Directives and Guidelines
    • C.8.5: New Rules on Importing Active Pharmaceutical Ingredients
      into the European Union
    • C.8.5.1: Importation of Active Substances for Medicinal Products
      for Human Use Questions and Answers
    • C.13: Guideline on Real Time Release Testing
  • Chapter D: USA: CFR and FDA Guidelines
    • D.13: Incorporation of Physical-Chemical Identifiers into Solid Oral
      Dosage Form Drug Products for Anticounterfeiting
  • Chapter E: ICH Guidelines
    • E.7: ICH Q7 / APIC How-to-do Document
  • Chapter G: GMP of other Regions
    • G.1.4: WHO TRS 961 (2011), Annex 9: Model Guidance for the Storage
      and Transport of Time- and Temperature-sensitive Pharmaceutical
      Products (online only)

Updated Chapters:

  • Chapter C: EU Directives and Guidelines
    • C.4.1: EU GMP Guide Part I, Chapter 1
    • C.4.7: EU GMP Guide Part I, Chapter 7
    • C.6.2: EU GMP Guide Annex 2
  • Chapter D: USA: CFR and FDA Guidelines
    • D.1.1: 21 CFR Part 210
    • D.1.2: 21 CFR Part 211
    • D.1.3: 21 CFR Part 11
    • D.1.4: 21 CFR Part 820 (formerly chapter D.13)
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Thu, 11 Oct 2012 22:00:00 +0000
<![CDATA[LOGFILE No. 28/2012 - Pharmaceutical Quality System (EU-GMP Chapter 1)]]> http://gmpupdate.swhosting6.de/en/lead-article/gmp-aktuell/gmp-logfile-28-2012-pharmaceutical-quality-system-eu-gmp-guide-chapter-1.html Comparison of Different Versions of Chapter 1 EU Guide to GMP Part I

(October 2012)

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Tue, 09 Oct 2012 22:00:00 +0000
<![CDATA[EC:Falsified Medicines Concept Paper]]> http://gmpupdate.swhosting6.de/en/gmp-news/gmp-aktuell/EC-falsified-medicines-concept-paper.html The EC has published  a concept paper for public consultation on "The delegated act on the criteria to be considered and the verifications to be made when assessing the potential falsified character of medicinal products introduced in the Union but not intended to be placed on the market".

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Mon, 08 Oct 2012 22:00:00 +0000
<![CDATA[FDA: Action against illegal sale of unapproved drugs]]> http://gmpupdate.swhosting6.de/en/gmp-news/gmp-aktuell/FDA-action-illegal-sale-drugs.html The U.S. Food and Drug Administration, in partnership with international regulatory and law enforcement agencies, took action this week against more than 4,100 Internet pharmacies that illegally sold potentially dangerous, unapproved drugs to consumers. It resulted in the shutdown of more than 18,000 illegal pharmacy websites and the seizure of about $ 10.5 million worth of pharmaceuticals worldwide.

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Mon, 08 Oct 2012 22:00:00 +0000
<![CDATA[LOGFILE No. 27/2012 - Europe: New "Outsourced Activities"]]> http://gmpupdate.swhosting6.de/en/lead-article/gmp-aktuell/gmp-logfile-27-2012-new-outsourced-activities-eu-gmp-guide-chapter-7.html Synopsis of Chapter 7 of the EU Guide to GMP

(September 2012)

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Tue, 25 Sep 2012 22:00:00 +0000
<![CDATA[SFDA: New Requirements for Excipients]]> http://gmpupdate.swhosting6.de/en/gmp-news/gmp-aktuell/SFDA-requirements-pharmaceutical-excipients.html The Chinese State Food and Drug Administration (SFDA) has released the relevant requirements on strengthening supervision and management of pharmaceutical excipients.

mehr]]>
Sun, 23 Sep 2012 22:00:00 +0000
<![CDATA[LOGFILE No. 26/2012 - Good Distribution Practice (GDP)]]> http://gmpupdate.swhosting6.de/en/lead-article/gmp-aktuell/logfile-26-2012-gdp-current-regulations.html Good Distribution Practice - Current Regulations

Author: Thomas Peither, Maas & Peither AG, GMP Publishing

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Wed, 19 Sep 2012 22:00:00 +0000
<![CDATA[EU-GMP: Revised Chapter 1” Pharmaceutical Quality System” published]]> http://gmpupdate.swhosting6.de/en/gmp-news/gmp-aktuell/EU-GMP-chapter-one-1-pharmaceutical-quality-system.html Long awaited, DG SANCO (Directorate-General for Health and Consumers of the European Commission) has finally published the amended Chapter 1 of the EU GMP Guide on Pharmaceutical Quality System.

It will enter into force on 31 January 2013.

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Thu, 13 Sep 2012 22:00:00 +0000
<![CDATA[EU-GMP: Amended Chapter 7 "Outsourced Activities" published]]> http://gmpupdate.swhosting6.de/en/gmp-news/gmp-aktuell/EU-GMP-chapter-seven-outsourced-activities.html Long awaited, DG SANCO (Directorate-General for Health and Consumers of the European Commission) has finally published the amended Chapter 7 of the EU-GMP Guide on Outsourced Activities.

It will enter into force on 31 January 2013.

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Thu, 13 Sep 2012 22:00:00 +0000
<![CDATA[EU-GMP: Revised Annex 2 “Biological Active Substances” published]]> http://gmpupdate.swhosting6.de/en/gmp-news/gmp-aktuell/EU-GMP-annex-two-2-biological-active-substances.html Long awaited, DG SANCO (Directorate-General for Health and Consumers of the European Commission) has now launched the publication of Annex 2 of the EU-GMP Guide on Biological Active Substances.

It will enter into force on 31 January 2013.

mehr]]>
Thu, 13 Sep 2012 22:00:00 +0000
<![CDATA[LOGFILE No. 25/2012 - Typical GMP Audit Questions]]> http://gmpupdate.swhosting6.de/en/lead-article/gmp-aktuell/logfile-25-2012-gmp-audit-questions-on-electronic-records.html 10 typical GMP audit questions about electronic records
LOGFILE-25-2012-Electronic-Records-Audit-Questions.pdf
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Tue, 21 Aug 2012 22:00:00 +0000
<![CDATA[EMA: Veterinary Causality Assessment Concept Paper]]> http://gmpupdate.swhosting6.de/en/gmp-news/gmp-aktuell/EMA-concept-paper-causality-assessment-veterinary-products.html The EMA has published a "Concept paper for revision of the guideline on harmonising the approach to causality assessment for adverse reactions to veterinary medicinal products". The guideline aims to describe how causality assessment should be performed in a harmonised way by all involved parties.

mehr]]>
Sun, 19 Aug 2012 22:00:00 +0000
<![CDATA[ICH: Steering Committee Meeting]]> http://gmpupdate.swhosting6.de/en/gmp-news/gmp-aktuell/ich-steering-committee-meeting.html The International Conference on Harmonisation (ICH) Steering Committee (SC) and its Expert Working Groups (EWGs) met in Fukuoka, Japan on June 2-7, 2012. The ICH parties agreed on new principles of governance for robust science-based guidelines for the review of the safety, efficacy, and quality of medicinal products. In addition, ICH confirmed its commitment to strengthen its global outreach. Further progress was made on the individual topics, notably the Electronic Common Technical Document (eCTD) (ICH M8).

mehr]]>
Mon, 06 Aug 2012 22:00:00 +0000
<![CDATA[EMA: Interaction between EMA and Japan]]> http://gmpupdate.swhosting6.de/en/gmp-news/gmp-aktuell/EMA-interaction-Japan.html Over the last three years, the European Medicines Agency has increased the level of interaction and cooperation with medicines regulatory authorities in Japan. There has been a growing information exchange and an interaction on areas of mutual interests between Japanese and European authorities.

mehr]]>
Sun, 05 Aug 2012 22:00:00 +0000
<![CDATA[Information leaflet: New rules on importing APIs into the EU]]> http://gmpupdate.swhosting6.de/en/gmp-news/gmp-aktuell/information-leaflet-import-APIs.html The European Commission has published an information leaflet regarding the newly reformed rules on importing active pharmaceutical ingredients into the EU.

mehr]]>
Mon, 30 Jul 2012 22:00:00 +0000
<![CDATA[Rx-360: Supply Chain Security White Paper ]]> http://gmpupdate.swhosting6.de/en/gmp-news/gmp-aktuell/rx-360-white-paper-supply-chain-security.html Rx-360 has released the "Rx-360 Supply Chain Security White Paper:  Audits and Assessments of Third Party Warehousing and Distribution Facilities," a Template of Requirements for Third Party Logistics Service Providers, and an Audit Tool focused on Third Party Logistics Service Providers.

mehr]]>
Thu, 19 Jul 2012 22:00:00 +0000
<![CDATA[EMA: Transgenic Animal Technology - Draft Guideline]]> http://gmpupdate.swhosting6.de/en/gmp-news/gmp-aktuell/ema-draft-guideline-transgenic-animal-technology.html The EMA has published a draft guideline on quality of biological active substances produced by transgene expressions in animals for public consultations. This guideline provides guidance on the approaches that should be employed in order to achieve satisfactory quality for biological drug substances proposed to be produced using transgenic animal technology.

mehr]]>
Wed, 18 Jul 2012 22:00:00 +0000
<![CDATA[LOGFILE No. 22/2012 - Contract Manufacturer Agreement]]> http://gmpupdate.swhosting6.de/en/lead-article/gmp-aktuell/gmp-logfile-22-2012-contract-manufacturer-agreement-requirements.html Contract manufacturer agreement

Author: Max Lazar

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Tue, 17 Jul 2012 22:00:00 +0000
<![CDATA[EC: Import of Active Substances]]> http://gmpupdate.swhosting6.de/en/gmp-news/gmp-aktuell/european-commission-ec-import-of-active-substances.html The European Commission has published the final template for the written confirmation for active substances exported to the European Union for medicinal products for human use. The new template has been published in Part III of EudraLex, Volume 4.

mehr]]>
Thu, 12 Jul 2012 22:00:00 +0000
<![CDATA[LOGFILE No. 21/2012 - Laboratory Controls - GMP Audit Questions]]> http://gmpupdate.swhosting6.de/en/lead-article/gmp-aktuell/gmp-logfile-21-2012-typical-audit-questions-laboratory-controls.html Typical Audit Questions: Laboratory Controls

LOGFILE-21-2012-Laboratory-Controls-Audit-Questions.pdf

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Tue, 03 Jul 2012 22:00:00 +0000
<![CDATA[EMA: New GDP documents in CoCP]]> http://gmpupdate.swhosting6.de/en/gmp-news/gmp-aktuell/EMA-new-documents-CoCP-community-procedures-GDP.html The Compilation of Community Procedures on Inspections and Exchange of Information (Revision 14) (CoCP) has been adopted on 25 May 2012 and will enter into force in January 2013. Various new "Forms used by regulators" were added.

mehr]]>
Thu, 28 Jun 2012 22:00:00 +0000
<![CDATA[LOGFILE No. 20/2012 - Top 10 GMP Deficiencies]]> http://gmpupdate.swhosting6.de/en/lead-article/gmp-aktuell/gmp-logfile-20-2012-top-10-gmp-deficiencies-of-pics-members.html The Top 10 GMP Deficiencies of PIC/S Members

Author:
Thomas Peither
Maas & Peither GMP Publishing, Germany, USA

 

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Tue, 26 Jun 2012 22:00:00 +0000
<![CDATA[WHO: World Pharmacopoeias Meeting]]> http://gmpupdate.swhosting6.de/en/gmp-news/gmp-aktuell/WHO-international-meeting-world-pharmacopoeias.html For the first time in 10 years, representatives from pharmacopoeias from 23 countries came together on 29 February – 2 March 2012 at WHO headquarters in Geneva and committed to working further towards harmonization and strengthening WHO's role when developing global standards for the production and testing of medicines.

mehr]]>
Sun, 24 Jun 2012 22:00:00 +0000
<![CDATA[LOGFILE No. 19/2012 - Site Master File (SMF)]]> http://gmpupdate.swhosting6.de/en/lead-article/gmp-aktuell/gmp-logfile-19-2012-site-master-file-guidelines.html Site Master File – Guidelines for structure, contents and extent

Author: Cornelia Wawretschek, GxP Services

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Mon, 18 Jun 2012 22:00:00 +0000
<![CDATA[EMA: Biosimilar Medicines - Revised Guideline]]> http://gmpupdate.swhosting6.de/en/gmp-news/gmp-aktuell/EMA-revised-guideline-biosimilar-medicines.html The European Medicines Agency has released a revised guideline for public consultation describing how pharmaceutical companies should address the quality aspects of biosimilar medicines. The guideline updates the previous guidance from 2006, and explains the requirements for the manufacture and comparability testing for biological medicines claiming to be similar to another medicine already on the market.

mehr]]>
Thu, 14 Jun 2012 22:00:00 +0000
<![CDATA[LOGFILE No. 18/2012 - GMP and Personalized Medicine]]> http://gmpupdate.swhosting6.de/en/lead-article/gmp-aktuell/gmp-logfile-18-2012-gmp-and-personalized-medicine-pda-annual-meeting.html GMP and Personalized Medicine

Author:
Thomas Peither, Maas & Peither AG

Biotechnology took over the development of new drugs and personalized medicine is about to deliver first success stories. Presentations at the PDA Annual Meeting 2012 reported of first successes in cell based therapies.

mehr]]>
Tue, 05 Jun 2012 22:00:00 +0000
<![CDATA[Foundation of a new French Health Regulation Authority]]> http://gmpupdate.swhosting6.de/en/gmp-news/gmp-aktuell/ANSM-foundation-new-french-health-regulation-authority-former-AFSSAPS.html On 1 May 2012, the new "National Drug and Health Products Safety Agency / Agence nationale de sécurité du médicament et des produits de santé" (ANSM) was found.

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Tue, 29 May 2012 22:00:00 +0000
<![CDATA[EC: API Import Template (Draft)]]> http://gmpupdate.swhosting6.de/en/gmp-news/gmp-aktuell/GMP-EC-EU-API-import-draft-template.html The European Commission has published a draft template"Written confirmation for active substances imported into the European Union (EU) for medicinal products for human use" in accordance with article 46b(2)(b) of Directive 2001/83/EC1, for public consultation.

mehr]]>
Tue, 22 May 2012 22:00:00 +0000
<![CDATA[LOGFILE No. 17/2012 - Transfer of qualification activities to suppliers]]> http://gmpupdate.swhosting6.de/en/lead-article/gmp-aktuell/gmp-logfile-17-2012-transfer-of-qualification-activities-to-suppliers.html Outsourcing qualification activities to suppliers

Image

Image

Authors:
Ulrike Reuter, Germany
Max Lazar, USA

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Tue, 22 May 2012 22:00:00 +0000
<![CDATA[LOGFILE No. 16/2012 - Computer System Validation]]> http://gmpupdate.swhosting6.de/en/lead-article/gmp-aktuell/gmp-logfile-computer-system-validation-the-v-model.html The “V model”

Author: Markus Roemer,
comes compliance services

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Tue, 15 May 2012 22:00:00 +0000
<![CDATA[ICH Q11 now in Step 5 of the ICH Process]]> http://gmpupdate.swhosting6.de/en/gmp-news/gmp-aktuell/GMP-ICH-Q11-now-in-step-5-of-the-ich-process.html The ICH Q11 Guideline on Development and Manufacture of Drug Substances (Chemical Entities and Biotechnological/Biological Entities) reached Step 4 of the ICH Process on 1 May 2012 and now enters the Implementation phase (Step 5).

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Mon, 14 May 2012 22:00:00 +0000
<![CDATA[LOGFILE No. 15/2012 - GMP Risk Analysis RA 2x5]]> http://gmpupdate.swhosting6.de/en/lead-article/gmp-aktuell/gmp-logfile-risk-analysis-ra2x5-thomas-peither.html Risk Analysis RA2x5

Author: Thomas Peither,
Halfmann Goetsch Peither AG
Maas & Peither AG GMP Publishing

mehr]]>
Tue, 08 May 2012 22:00:00 +0000
<![CDATA[FDA: Sterility Testing of Biologics - Final Rule]]> http://gmpupdate.swhosting6.de/en/gmp-news/gmp-aktuell/FDA-GMP-final-rule-sterility-testing-biological-products.html The U.S. Food and Drug Administration issued its final rule on sterility testing, amending the requirements for most licensed biological products.

mehr]]>
Mon, 07 May 2012 22:00:00 +0000
<![CDATA[LOGFILE No. 14/2012 - EMA Draft for Process Validation]]> http://gmpupdate.swhosting6.de/en/lead-article/gmp-aktuell/gmp-logfile-14-2012-ema-draft-for-process-validation.html EMA Draft for Process Validation

Author: Thomas Peither

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Tue, 01 May 2012 22:00:00 +0000
<![CDATA[FDA: New 21 CFR Part 211 Amendment]]> http://gmpupdate.swhosting6.de/en/gmp-news/gmp-aktuell/FDA-21-cfr-211-cGMP-amendment-new.html The Food and Drug Administration (FDA) is amending the packaging and labeling control provisions of the current good manufacturing practice (CGMP) regulations for human and veterinary drug products by limiting the application of special control procedures for the use of cut labeling to immediate container labels, individual unit cartons, or multiunit cartons containing immediate containers that are not packaged in individual unit cartons.

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Sun, 29 Apr 2012 22:00:00 +0000
<![CDATA[FDA: Global Engagement Report released]]> http://gmpupdate.swhosting6.de/en/gmp-news/gmp-aktuell/FDA-global-engagement-report-released.html The U.S. Food and Drug Administration Commissioner Margaret A. Hamburg, M.D. released the agency’s “Global Engagement Report”, detailing the many activities and strategies FDA is using to transform from a domestic to a global public health agency. The 44 pages report highlights the steps the agency is taking to ensure that imported food, drugs, medical devices, and other regulated products meet the same rigorous standards for safety and quality as those manufactured domestically.

mehr]]>
Thu, 26 Apr 2012 22:00:00 +0000
<![CDATA[EMA: Guideline on Real Time Release Testing]]> http://gmpupdate.swhosting6.de/en/gmp-news/gmp-aktuell/GMP-news-EMA-guideline-real-time-release-testing.html The guideline outlines the requirements for applications that propose RTR (real time release) testing for active substances, intermediates and finished products. It also outlines the different requirements that have to be fulfilled in the application and the need for interaction between quality assessors and GMP inspectors in the approval process.

mehr]]>
Tue, 24 Apr 2012 22:00:00 +0000
<![CDATA[LOGFILE No. 13/2012 - Commenting on USP Standards]]> http://gmpupdate.swhosting6.de/en/lead-article/gmp-aktuell/gmp-logfile-13-2012-the-importance-of-commenting-on-usp-standards.html The Importance of Commenting on Public Standards

Authors:
Sue Schniepp, OSO Biopharmaceutical and
Janeen Skutnik-Wilkinson, Pfizer

mehr]]>
Tue, 24 Apr 2012 22:00:00 +0000
<![CDATA[PIC/S: Japan and Korea Applies for Membership]]> http://gmpupdate.swhosting6.de/en/gmp-news/gmp-aktuell/gmp-news-pics-japan-and-korea-applies-for-membership.html Japan and Korea resently applied for PIC/S membership.

mehr]]>
Sun, 22 Apr 2012 22:00:00 +0000
<![CDATA[LOGFILE No. 12/2012 - Qualification of Personnel]]> http://gmpupdate.swhosting6.de/en/lead-article/gmp-aktuell/qualification-personnel-aseptic-processing-gmp-logfile.html Aseptic Processing: Qualification of personnel

Author:
Dipl.-Ing. (FH) Ruven Brandes, WDT eG, Germany

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Tue, 17 Apr 2012 22:00:00 +0000
<![CDATA[EMA: Process Validation Draft Published]]> http://gmpupdate.swhosting6.de/en/gmp-news/gmp-aktuell/EMA-published-draft-gmp-process-validation-guideline.html A new draft of the process validation guideline was published by EMA (European Medicines Ageny) on April 13, 2012,

mehr]]>
Sun, 15 Apr 2012 22:00:00 +0000
<![CDATA[New PIC/S Aide-Mémoire PI 038-1]]> http://gmpupdate.swhosting6.de/en/gmp-news/gmp-aktuell/pics-aide-mémoire-on-assessment-of-quality-risk-management-implementation.html The PIC/S Committee has adopted an Aide-Mémoire on Assessment of Quality Risk Management Implementation (PI 038-1), which entered  into force on 2 April 2012.

mehr]]>
Thu, 12 Apr 2012 22:00:00 +0000
<![CDATA[FDA: New guidance on considerations used in device approval, de novo decisions]]> http://gmpupdate.swhosting6.de/en/gmp-news/gmp-aktuell/new-fda-guidance-device-approval.html The U.S. Food and Drug Administration today published a first-of-a-kind guidance for medical device manufacturers, describing how the benefits and risks of certain medical devices are considered during pre-market review.

mehr]]>
Tue, 03 Apr 2012 22:00:00 +0000
<![CDATA[LOGFILE No. 11/2012 - GDPs for Excipients]]> http://gmpupdate.swhosting6.de/en/lead-article/gmp-aktuell/gmp-logfile-11-2012-good-distribution-practices-for-excipients-ipq.html USP and IPEC-Europe Weigh in on GDPs for Excipients

An article by IPQ Publications

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Tue, 03 Apr 2012 22:00:00 +0000
<![CDATA[FDA: Guidance Agenda for 2012]]> http://gmpupdate.swhosting6.de/en/gmp-news/gmp-aktuell/fda-guidance-agenda-for-2012.html The FDA/CDER has issued a guidance agenda for 2012 which lists the planned draft documents as well as the final guidance documents for the ongoing year.

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Sun, 01 Apr 2012 22:00:00 +0000
<![CDATA[PIC/S - risk-based inspection planning]]> http://gmpupdate.swhosting6.de/en/gmp-news/gmp-aktuell/pics-risk-based-inspection-planning.html The PIC/S recommendation PI 037-1 intends to work as a simple and flexible quality risk management tool serving inspectorates when planning the frequency and scope of GMP. The methodology is based upon the concept of rating manufacturing sites on basis of an estimated risk that they may pose to patients, consumers, animals and users of medicines. The methodology also takes into account the risk to product quality.

mehr]]>
Tue, 27 Mar 2012 22:00:00 +0000
<![CDATA[LOGFILE No. 10/2012 - Medical Devices - Customer Complaints]]> http://gmpupdate.swhosting6.de/en/lead-article/gmp-aktuell/gmp-logfile-10-2012-medical-devices-customer-complaints.html Customer complaints

ImageImageImage

Authors: Katherine M. Wortley, Ph. D., Sherry Leichtweis, Dr. jur. Volker Lücker

Here you will find answers to the following questions:

  • What are the requirements for complaint management?
  • Who is responsible for complaint management?
  • What is necessary for complaint evaluation and investigation?
mehr]]>
Tue, 27 Mar 2012 22:00:00 +0000
<![CDATA[Chinese GMP Regulations in English]]> http://gmpupdate.swhosting6.de/en/gmp-news/gmp-aktuell/chinese-GMP-regulations-in-english-good-manufacturing-practices.html The State Food and Drug Administration, P.R. China (SFDA) has recently published the revised “Good Manufacturing Practice for Drugs” in English. The original document in Chinese, adopted at the executive meeting of the Ministry of Health, went into effect on March 1, 2011.

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Tue, 20 Mar 2012 23:00:00 +0000
<![CDATA[LOGFILE No. 09/2012 - Quality by Design (QdB)]]> http://gmpupdate.swhosting6.de/en/lead-article/gmp-aktuell/logfile-9-2012-the-new-quality-paradigm-quality-by-design.html The New Quality Paradigm

Author: Dr. Siegfried Schmitt

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Tue, 20 Mar 2012 23:00:00 +0000
<![CDATA[USP: GDP-Supply Chain Integrity]]> http://gmpupdate.swhosting6.de/en/gmp-news/gmp-aktuell/USP-GDP-Supply-Chain-Integrity-Good-Distribution-Practice.html The USP Pharmacopeial Forum has announced the proposal of a new general information chapter <1083> Good Distribution Practices – Supply Chain Integrity.

mehr]]>
Mon, 19 Mar 2012 23:00:00 +0000
<![CDATA[LOGFILE No. 07/2012 - GMP Inspection of suppliers]]> http://gmpupdate.swhosting6.de/en/lead-article/gmp-aktuell/gmp-inspection-of-suppliers-logfile-march.html Inspection of suppliers
Image Image

Authors: Dr. Michael Hiob, Max Lazar

Here you will find answers to the following questions:

  • What is the purpose of supplier inspec-tions?
  • What should be considered when carry-ing out an inspection?
  • Under what conditions is it acceptable to recognize supplier inspections within a pool of companies (customers)?
  • What should be taken into consideration during inspections of software manufacturers?
mehr]]>
Tue, 13 Mar 2012 23:00:00 +0000
<![CDATA[EMA: Reflection paper on use of starting materials]]> http://gmpupdate.swhosting6.de/en/gmp-news/gmp-aktuell/EMA-reflection-paper-on-starting-materials.html The European Medicine Agency EMA has published a draft of the “Reflection Paper on the use of starting materials and intermediates collected from different sources in the manufacturing of biological medicinal products”.

mehr]]>
Mon, 12 Mar 2012 23:00:00 +0000
<![CDATA[ICH E2C(R2) reaches Step 2 ]]> http://gmpupdate.swhosting6.de/en/gmp-news/gmp-aktuell/ICH-E2C-R2-step2-risk-evaluation-report.html The ICH E2C(R2) Guideline on Periodic Benefit-Risk Evaluation Report reached Step 2 of the ICH Process in February 2012 and now enters the consultation period (Step 3).

mehr]]>
Sun, 11 Mar 2012 23:00:00 +0000
<![CDATA[GMP MANUAL Update No. 13]]> http://gmpupdate.swhosting6.de/en/gmp-news-updates/gmp-aktuell/13-update-gmp-manual-april.html The recent update of the GMP MANUAL encompasses approx. 590 pages for the print version and nearly 300 additional pages for the CD and online versions.
Due to the continuous expansion of the contents of the GMP MANUAL – currently the inclusion of the extensive directive 2001/83/EC (“Pharma-Directive”) – we faced the necessity to introduce a new file for the “GMP Regulations” part. You will find a detailed description of the change procedure for the files in the update instruction (printed version only).

The contents of Update 13 are outlined below:

“GMP in Practice"

New Chapters:

  • Chapter 12: Sterile Production
    • Chapter 12.A: Introduction
    • Chapter 12.C: Manufacture of terminally sterilised products
    • Chapter 12.D: Sterilisation processes
    • Chapter 12.E: Aseptic processing
    • Chapter 12.K: References
  • Chapter 16: Research and Development
    • Chapter 16.G: Quality by Design
    • Chapter 16.H: References
  • Chapter 18: Inspections
    • Chapter 18.I: Inspection of API manufacturers

Updated Chapters:

  • Chapter 12: Sterile Production
    • Chapter 12.B: Airlock concepts
  • Chapter 18: Inspections
    • Chapter 18.J: References

“GMP Regulations”

New Chapters:

  • Chapter C: EU Directives and Guidelines
    • C.12: EU Directive 2001/83/EC
  • Chapter F: PIC/S Guidelines
    • F.9: PIC/S PE 009-9 (GMP Guide): Introduction
    • F.10: PIC/S PE 009-9 (GMP Guide): Part I
    • F.11: PIC/S PE 009-9 (GMP Guide): Part II
    • F.12: PIC/S PE 009-9 (GMP Guide): Annexes
  • Chapter G: GMP of other regions (CD and online only):
    • G.4: Chinese GMP

Updated Chapters:

  • Chapter G: GMP of other regions (CD and online only):
    • G.2: Canadian Regulations
  • Chapter H: Information:
    • H.4: References
mehr]]>
Wed, 07 Mar 2012 23:00:00 +0000
<![CDATA[FDA: Draft Guidance on Heparin]]> http://gmpupdate.swhosting6.de/en/gmp-news/gmp-aktuell/FDA-draft-heparin.html The draft guidance “Heparin for Drug and Medical Device Use: Monitoring Crude Heparin for Quality” has been released by the FDA. It contains recommendations to help manufacturers of active pharmaceutical ingredients (APIs), pharmaceutical and medical device manufacturers of finished products to better control the use of crude heparin regarding any possible contaminations, especially oversulfated chondroitin sulfate (OSCS).

mehr]]>
Thu, 23 Feb 2012 23:00:00 +0000
<![CDATA[LOGFILE No. 06/2012 - Monitoring of HVAC systems]]> http://gmpupdate.swhosting6.de/en/lead-article/gmp-aktuell/gmp-logfile-06-2012-monitoring-of-hvac-systems.html Monitoring of HVAC Systems
  • Objectives of process monitoring
  • Data management stipulations
  • Air cleanliness and other room air data

Author: Dr. Hans Schicht

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Tue, 21 Feb 2012 23:00:00 +0000
<![CDATA[LOGFILE No. 05/2012 - Pharmaceutical Water]]> http://gmpupdate.swhosting6.de/en/lead-article/gmp-aktuell/pharmaceutical-water-quality-requirements-for-pure-steam.html Quality requirements for pure steam

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Authors:
Martin Essmann, Germany
Dr. Ralph Gomez, USA

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Tue, 14 Feb 2012 23:00:00 +0000
<![CDATA[EXCiPACT - Excipients GMP and GDP Certification]]> http://gmpupdate.swhosting6.de/en/gmp-news/gmp-aktuell/EXCiPACT-launched-gmp-gdp-certification-for-excipients.html On 1st February 2012, the IPEC Federation has launched its new, voluntary international certification scheme, designed and developed to assure cGMP and cGDP standards are being used in the manufacture and supply of pharmaceutical excipients, named EXCiPACT.

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Tue, 14 Feb 2012 23:00:00 +0000
<![CDATA[FDA: Biosimilar Product Draft Guidelines]]> http://gmpupdate.swhosting6.de/en/gmp-news/gmp-aktuell/FDA-draft-biosimilar-draft-guidelines-2012.html The U.S. Food and Drug Administration today issued three draft guidance documents on biosimilar product development to assist industry in developing such products in the United States.

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Mon, 13 Feb 2012 23:00:00 +0000
<![CDATA[LOGFILE No. 04/2012 - GMP Guidelines 2012]]> http://gmpupdate.swhosting6.de/en/lead-article/gmp-aktuell/logfile-4-2012-gmp-guidelines-2012.html GMP-Guidelines: What can we expect in 2012?

Author: Anita Maas, Maas & Peither AG

 

Here it is – the year 2012 blessed with plenty of predictions has begun. It remains to be seen whether and in which areas the signalized changes will occur. One thing is for sure: There will be further development in the field of GMP. What has to be expected this year was summarized by Dr. Wanninger, GMP inspector, at the 17th GMP-Conference in November 2011 in Mainz, Germany.

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Tue, 07 Feb 2012 23:00:00 +0000
<![CDATA[FDA: Medical Device User Fees ]]> http://gmpupdate.swhosting6.de/en/gmp-news/gmp-aktuell/FDA-industry-medical-device-user-fees-GMP.html The FDA and representatives from the medical device industry have reached an agreement in principle on proposed recommendations for the third reauthorization of a medical device user fee program. The recommendations would authorize the FDA to collect $595 million in user fees over five years, plus adjustments for inflation. Details of the agreement, such as the fee structure, are expected to be finalized soon.

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Mon, 06 Feb 2012 23:00:00 +0000
<![CDATA[Revised PIC/S Scheme entered into force on 1 January 2012]]> http://gmpupdate.swhosting6.de/en/gmp-news/gmp-aktuell/pics-scheme-january.html The revised PIC/S Scheme which was formally adopted at the PIC/S Committee Meeting in November 2011 entered  into force on 1 January 2012.

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Sun, 05 Feb 2012 23:00:00 +0000
<![CDATA[LOGFILE No. 03/2012 - Process Validation]]> http://gmpupdate.swhosting6.de/en/lead-article/gmp-aktuell/process-validation-from-the-viewpoint-of-the-fda.html Process validation from the viewpoint of the FDA

Authors:
Dr. Christine Oechslein, GMP Instructor, Germany
Max S. Lazar, FDA Regulatory Compliance Consulting, USA

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Tue, 31 Jan 2012 23:00:00 +0000
<![CDATA[EC: Active Substances in Medicinal Products]]> http://gmpupdate.swhosting6.de/en/gmp-news/gmp-aktuell/EC-Concept Paper-Active Substances-Medicinal Products.html The European Commission (EC) released a concept paper for public consultation concerning the principles and guidelines of good manufacturing practice for active substances in medicinal products for human use.

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Tue, 31 Jan 2012 23:00:00 +0000
<![CDATA[EMA: Draft Guideline on Risk-based Approach]]> http://gmpupdate.swhosting6.de/en/gmp-news/gmp-aktuell/EMA-draft-risk-based approach.html The EMA released a concept paper for public consultation concerning the risk-based approach according to Annex I, part IV of Directive 2001/83/EC applied to advanced-therapy medicinal products.

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Mon, 30 Jan 2012 23:00:00 +0000
<![CDATA[FDA proposes new Generic Drug User Fees]]> http://gmpupdate.swhosting6.de/en/gmp-news/gmp-aktuell/FDA-new-Generic Drug User Fees.html The FDA plans the implementation of new fees for the approval of generic drugs and - closely linked with this - for the inspection of producers and supplying manufacturers. The GDUFA (Generic Drug User Fee) is due to come into force on October 1, 2012

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Thu, 26 Jan 2012 23:00:00 +0000
<![CDATA[LOGFILE No. 02/2012 - Pharmaceutical Quality System (PQS)]]> http://gmpupdate.swhosting6.de/en/lead-article/gmp-aktuell/main-elements-of-a-pharmaceutical-gmp-quality-system.html Main Elements of a pharmaceutical quality system (PQS)
Management responsibility

Author: Lothar Hartmann Ph. D.

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Tue, 24 Jan 2012 23:00:00 +0000
<![CDATA[FDA's expectations of Janet Woodcock (CDER)]]> http://gmpupdate.swhosting6.de/en/gmp-news/gmp-aktuell/FDA-expectations-Janet-Woodcock-CDER.html How has the biopharma industry evolved over the last 25 years, and what can we expect from the industry in the next two and a half decades? Those were questions CDER director Janet Woodcock set out to answer at the 25th annual AAPS meeting in Washington, D.C..

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Sun, 22 Jan 2012 23:00:00 +0000
<![CDATA[Health Canada: Cleaning Validation Guidance]]> http://gmpupdate.swhosting6.de/en/gmp-news/gmp-aktuell/health-canada-cleaning-validation-guidance.html The Canadian Medicines Agency "Health Canada" published the Document "Cleaning Validation Guidance (GUI-0028)" for public consultation.

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Tue, 17 Jan 2012 23:00:00 +0000
<![CDATA[LOGFILE No. 1/2012 - January 2012]]> http://gmpupdate.swhosting6.de/en/lead-article/gmp-aktuell/contract-manufacture-duties-of-the-contract-giver.html Contract Manufacture: Duties of the Contract Giver

from Max S. Lazar

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Mon, 09 Jan 2012 23:00:00 +0000
<![CDATA[Health Canada: Process Validation Draft Guidance]]> http://gmpupdate.swhosting6.de/en/gmp-news/gmp-aktuell/health-canada-draft-guidance-process-validation.html The Canadian Medicines Agency "Health Canada" released the Draft Guidance on Process Validation "Terminal Sterilization Processes for Pharmaceutical Products (GUI-0074)" for public consultation.

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Sun, 08 Jan 2012 23:00:00 +0000
<![CDATA[EMA: Work Plan 2012]]> http://gmpupdate.swhosting6.de/en/gmp-news/gmp-aktuell/2012-ema-work-plan.html The European Medicines Agency (EMA) released the work programme for 2012.

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Wed, 04 Jan 2012 23:00:00 +0000
<![CDATA[TGA: Risk Management Plan Guideline - Draft]]> http://gmpupdate.swhosting6.de/en/gmp-news/gmp-aktuell/tga-risk-management-plan-guideline-draft.html The Australian Therapeutic Goods Administration (TGA) released a Draft Guideline concerning Risk Management Plans for public consultation.

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Thu, 22 Dec 2011 23:00:00 +0000
<![CDATA[EC Concept Paper: Active Substances]]> http://gmpupdate.swhosting6.de/en/gmp-news/gmp-aktuell/concept-paper-active-substances.html The European Commission (EC) released a concept paper for public consultation concerning the implementation of the regulatory framework applicable to the manufacturing of active substances imported to the EU from third countries.

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Tue, 20 Dec 2011 23:00:00 +0000
<![CDATA[LOGFILE No. 17/2011 - December 2011]]> http://gmpupdate.swhosting6.de/en/lead-article/gmp-aktuell/gmp-review-news.html REGULATORY UPDATE October 2011
INTRODUCTION

During October 2011 there have been a number of developments in the regulation of the pharmaceutical industry. In October all reported issues have come from the EU and USA regulatory authorities.

Europe

  • New Medicrime Convention to be launched in Russia
  • Pharmeuropa online
  • Technical guide for the elaboration of monographs – 6th edition
  • Handling of duplicate marketing authorization submissions
  • Guide to control and monitoring of storage and transportation temperature conditions for medicinal products and active substances.
  • IMB, Customs and Gardai in global INTERPOL operation

USA

  • New transparency report outlines proposals for enforcement data
  • Inspectional observation summaries
  • Q&A about pathogenic agent contamination of animal-derived drug ingredients
  • Guidance for Industry Incorporation of PhysicalChemical Identifiers into Solid Oral Dosage Form Drug Products for Anticounterfeiting
  • Guidance for Industry- Warnings and Precautions, Contraindications, and Boxed Warning Sections of Labeling Content and Format
  • Draft Guidance on Media Fills for Validation of Aseptic Preparations for Positron Emission Tomography Drugs

RECENT DEVELOPMENTS IN GMP AND REGULATORY REQUIREMENTS.

You want to get this monthly information on a regular base? You are one click away to get the GMP REVIEW from our partner company. Order the GMP REVIEW today!

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Tue, 13 Dec 2011 23:00:00 +0000
<![CDATA[EMA and FDA share manufacturing site inspections]]> http://gmpupdate.swhosting6.de/en/gmp-news/gmp-aktuell/ema-and-fda-share-manufacturing-site-inspections.html The European Medicines Agency and the U.S. Food and Drug Administration (FDA) are starting an initiative to share work on inspections of manufacturing sites.

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Sun, 11 Dec 2011 23:00:00 +0000
<![CDATA[ICH New Documents (November Meeting)]]> http://gmpupdate.swhosting6.de/en/gmp-news/gmp-aktuell/ich-november-meeting-new-documents.html The International Conference on Harmonisation (ICH) Steering Committee and its working groups met in Spain from November 5 - 10, 2011. Among other topics, there were three quality documents finished.

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Wed, 07 Dec 2011 23:00:00 +0000
<![CDATA[EMA: Dedicated Facilities]]> http://gmpupdate.swhosting6.de/en/gmp-news/gmp-aktuell/ema-dedicated-facilities.html In October 2011 the European Medicines Agency EMA published an new concept paper concerning dedicated facilities.

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Sun, 04 Dec 2011 23:00:00 +0000
<![CDATA[Europe: Unique Identifiers for Medicinal Products (Concept Paper)]]> http://gmpupdate.swhosting6.de/en/gmp-news/gmp-aktuell/Europe: concept-paper-unique-identifiers-medicinal-products.html The EC (European Commission) released a concept paper for public consultation. The document called "Delegated act on the detailed rules for a unique identifier for medicinal products for human use, and its verification" was published on November 18, 2011.

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Mon, 28 Nov 2011 23:00:00 +0000
<![CDATA[LOGFILE No. 15/2011 - November 2011]]> http://gmpupdate.swhosting6.de/en/lead-article/gmp-aktuell/which-GMP-risk-analysis-fits-best-good-manufacturing-practice-pharma.html Which Risk Assessment fits best?

ImageImage

Authors: S. Roenninger, M. Hertlein

This article addresses the following questions:

  • Which methods of risk management are referenced in ICH Q9?
  • Are there methods that are equally suitable for use across all areas of application?
  • How can these be used in practice?
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Mon, 28 Nov 2011 23:00:00 +0000
<![CDATA[PIC/S: New Members, new Topics]]> http://gmpupdate.swhosting6.de/en/gmp-news/gmp-aktuell/pics-new-mermbers-new-topics.html The PIC/S (Pharmaceutical Inspection Cooperation Scheme) Committee met from November 7 - 8, 2011 in Cape Town.

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Sun, 27 Nov 2011 23:00:00 +0000
<![CDATA[EU-GMP: Annex 14 in Operation]]> http://gmpupdate.swhosting6.de/en/gmp-news/gmp-aktuell/EU-GMP-14-annex-comming-into-operation.html The revised Annex 14 of the EU GPM Guide is comming into operation on November 30, 2011.

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Thu, 24 Nov 2011 23:00:00 +0000
<![CDATA[LOGFILE No. 14/2011 - November 2011]]> http://gmpupdate.swhosting6.de/en/lead-article/gmp-aktuell/temperature-profiles.html Temperature Profiles

Author: Nicola Spiggelkötter Ph. D.

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Mon, 14 Nov 2011 23:00:00 +0000
<![CDATA[EMA: Revision Annex 16]]> http://gmpupdate.swhosting6.de/en/gmp-news/gmp-aktuell/16-annex-ema-concept-paper.html The European Medicines Agency (EMA) released a concept paper on Annex 16 of the EU GMP Guide.

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Sun, 13 Nov 2011 23:00:00 +0000
<![CDATA[FDA: Bar Code Rule]]> http://gmpupdate.swhosting6.de/en/gmp-news/gmp-aktuell/fda-bar-code-rule.html In May 2011 we published a FDA proposal concerning the document review of existing regulations. The FDA Department of Health and Human Services (HHS) reviewed as a first regulation the so called “Bar Code Rule”.

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Tue, 08 Nov 2011 23:00:00 +0000
<![CDATA[EC: Concept Paper Pharmacovigilance]]> http://gmpupdate.swhosting6.de/en/gmp-news/gmp-aktuell/ec-concept-paper-pharmacovigilance.html The European Commission (EC) started a public consultation on a concept paper on implementing measures for the performance of pharmacovigilance activities.

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Sun, 30 Oct 2011 23:00:00 +0000
<![CDATA[WHO: HVAC Systems]]> http://gmpupdate.swhosting6.de/en/gmp-news/gmp-aktuell/who-hvac-systems.html WHO presents as part of it's Technical Report Series 961 in the issue 45 the document "Supplementary guidelines on good manufacturing practices for heating, ventilation and airconditioning systems for non-sterile pharmaceutical dosage forms".

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Tue, 18 Oct 2011 22:00:00 +0000
<![CDATA[Consultations on adoption of EU guidelines in Australia]]> http://gmpupdate.swhosting6.de/en/gmp-news/gmp-aktuell/consultations-adoption-eu-guidelines-in-australia.html The Australian Medicines Agency (TGA) launched a consultation concerning several EU Guidelines on Medicines.

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Mon, 17 Oct 2011 22:00:00 +0000
<![CDATA[FDA: Guidance for PET Drugs Manufacturers]]> http://gmpupdate.swhosting6.de/en/gmp-news/gmp-aktuell/fda-guidance-pet-drug-manufacturers.html US Food and Drug Adminsitration recently published a Guideline for PET (positron emission tomography) Drug Manufacturers.

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Sun, 16 Oct 2011 22:00:00 +0000
<![CDATA[EMA: Expert Database launched]]> http://gmpupdate.swhosting6.de/en/gmp-news/gmp-aktuell/ema-expert-database-launched.html The European Medicines Agency (EMA) recently launched its expert database. The database allows the public to directly search for the declarations of interests of all experts who have been nominated by competent authorities for medicines regulation across the EU.

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Sun, 16 Oct 2011 22:00:00 +0000
<![CDATA[Canada: Draft Guidance Medicinal Gases]]> http://gmpupdate.swhosting6.de/en/gmp-news/gmp-aktuell/canada-draft-guidance-medicinal-gases-HC.html The Canadian Drug Administration Health Canada recently issued a Draft Guidance on Medicinal Gases for consultation.

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Tue, 04 Oct 2011 22:00:00 +0000
<![CDATA[GMP MANUAL Update No. 12]]> http://gmpupdate.swhosting6.de/en/gmp-news-updates/gmp-aktuell/12-update-gmp-manual.html What is new?

The recent update of the GMP MANUAL encompasses approx. 850 pages. In early 2011, regulatory requirements on Documentation, Computer Validation and Process Validation have been updated and the revised versions of the respective documents were in the focus of the “GMP Regulations” part of Update 11. Meanwhile, the corresponding chapters in the “GMP in Practice” part were subject to an in-depth review and represent the principal items of the present Update 12.
Vice versa, chapter 23 on Medical Devices was introduced in the “GMP in Practice” part in Update 11 as a new topic, which will now be complemented by a chapter in the “GMP Regulations” part, including EU Directives which are the underlying regulatory documents in the European region.

The contents of Update 12 are outlined below:

“GMP in Practice”

New Chapters:

  • Chapter 7.E.4: Process validation as a three stage lifecycle model
  • Chapter 7.F: References
  • Chapter 9.H: References
  • Chapter 15.G: References

Updated Chapters:

  • Chapter 7: Process Validation
  • Chapter 9: Computer Validation
  • Chapter 15.E: Site Master File

“GMP Regulations"”

New Chapters:

  • Chapter C: EU Directives and Guideline
    • C.8.2: EU GMP Guide Part III: Quality Risk Management
    • C.8.3: EU GMP Guide Part III: Pharmaceutical Quality System
    • C.8.4: EU GMP Guide Part III: Internationally harmonised requirements for batch certification
    • C.11: EU Directives on Medical Devices

Updated Chapters:

  • Chapter C: EU Directives and Guidelines
    • C.6.14: Annex 14 Blood and Blood products
    • C.10: Compilation of Community Procedures
  • Chapter D: USA: CFR and FDA Guidelines
    • D.1.1: 21 CFR 210
  • Chapter F: PIC/S Guidelines
    • F.2: PIC/S PI 007-6 Recommendation on the Validation of Aseptic Processes
  • Chapter H Information:
    • H.1: Abbreviations
    • H.2: Glossary
    • H.3: Adresses
    • H.4: References
mehr]]>
Mon, 03 Oct 2011 22:00:00 +0000
<![CDATA[WHO: Time- and Temperature Sensitive Products]]> http://gmpupdate.swhosting6.de/en/gmp-news/gmp-aktuell/who-time-temperature-sensitive-products.html The WHO Expert Committee on Specifications for Pharmaceutical Preparations published it's 45th Pharmaceutical Report. Besides other cGmp topics it presents a Model Guidance for the Storage and Transport of Time- and Temperature-sensitive Pharmaceutical Products.

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Thu, 15 Sep 2011 22:00:00 +0000
<![CDATA[Concept Paper on Biotechnology (EMA)]]> http://gmpupdate.swhosting6.de/en/gmp-news/gmp-aktuell/concept-paper-on-biotechnology-ema.html EMAs Biologics Working Party (BWP) published a concept paper about the need for a guideline on process validation of medicinal products containing biotechnology derived proteins as an active substance.

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Sun, 11 Sep 2011 22:00:00 +0000
<![CDATA[ICH collaboration with Africa]]> http://gmpupdate.swhosting6.de/en/gmp-news/gmp-aktuell/ich-collaboration-with-africa.html The ICH (International Conference on Harmonization) Steering Committee announced the participation of the East African Community (EAC) as member of the ICH Global Cooperation Group (GCG).

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Tue, 23 Aug 2011 22:00:00 +0000
<![CDATA[ICH: Guide for ICH Q8/Q9/Q10]]> http://gmpupdate.swhosting6.de/en/gmp-news/gmp-aktuell/ich-guide-ich-q8-q9-q10.html On June 16, 2011 the ICH Steering Committee endorsed a new Points to Consider Document concerning the Implementation of Q8, Q9 and Q10 Guidelines.

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Tue, 16 Aug 2011 22:00:00 +0000
<![CDATA[Japan: Risk Management Plan - Draft Guidance]]> http://gmpupdate.swhosting6.de/en/gmp-news/gmp-aktuell/japan-risk-management-plan-draft-guidance.html The Japanese Pharmaceutical and Food Safety Bureau issued the English translation of the draft guidance concerning Risk Management Plan.

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Mon, 15 Aug 2011 22:00:00 +0000
<![CDATA[TGA's lifecycle approach to regulation]]> http://gmpupdate.swhosting6.de/en/gmp-news/gmp-aktuell/tga-gmp-lifecycle-approach-regulation.html The australian TGA (Therapeutic Goods Administration) published on June 30, 2011 some information concerning the lifecycle approach to regulation.

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Wed, 27 Jul 2011 22:00:00 +0000
<![CDATA[EC: Public consultation of the revised GDP guidelines]]> http://gmpupdate.swhosting6.de/en/gmp-news/gmp-aktuell/ec-public-consultation-revised-gdp-guidelines-eu.html Last friday the European Commission (EC) startet a public consultation on the revised guidelines for good distribution practices (GDP).

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Mon, 18 Jul 2011 22:00:00 +0000
<![CDATA[EDQM: Annual Report 2010]]> http://gmpupdate.swhosting6.de/en/gmp-news/gmp-aktuell/2010-edqm-annual-report.html The EDQM (European Directorate for the Quality of Medicines and Healthcare) published the Annual Report 2010.

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Wed, 13 Jul 2011 22:00:00 +0000
<![CDATA[EMA: Compilation of Community Procedures Version 13]]> http://gmpupdate.swhosting6.de/en/gmp-news/gmp-aktuell/13-version-ec-compilation-community-procedures.html The European Medicines Agency (EMA) issued version 13 of the "Compilation of Community Procedures on Inspections and Exchange of Information".

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Tue, 12 Jul 2011 22:00:00 +0000
<![CDATA[ICH Q11 consultation period]]> http://gmpupdate.swhosting6.de/en/gmp-news/gmp-aktuell/Q11-ich-consultation-period.html The ICH Q11 Guideline on Development and Manufacture of Drug Substances (Chemical Entities and Biotechnological/Biological Entities) now enters the consultation period (Step 3).

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Sun, 10 Jul 2011 22:00:00 +0000
<![CDATA[EU: New in Part III GMP Guide]]> http://gmpupdate.swhosting6.de/en/gmp-news/gmp-aktuell/3-part-eu-gmp-guide-new-document-ec.html The Part III of EU GMP Guideline became expanded by a new document concerning MRA Batch Certificates.

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Wed, 06 Jul 2011 22:00:00 +0000
<![CDATA[EU: Falsified Medicines Guidelinie published]]> http://gmpupdate.swhosting6.de/en/gmp-news/gmp-aktuell/eu-falsified-medicines-guideline-published.html Last friday the so called "Falsified Medicines Guidelinies" was published in the Official Journal of the European Union.

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Mon, 04 Jul 2011 22:00:00 +0000
<![CDATA[EU: Concept Paper on Chapter 8 - Update]]> http://gmpupdate.swhosting6.de/en/gmp-news/gmp-aktuell/8-chapter-concept-paper-eu-update.html The public consultation on revising chapter 8 of the European Commission Guide to Good Manufacturing Practice is open since April 2011. Since last week, there is an updated document available.

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Sun, 26 Jun 2011 22:00:00 +0000
<![CDATA[PIC/S: Extending Mandate to GDP]]> http://gmpupdate.swhosting6.de/en/gmp-news/gmp-aktuell/pics-extending-mandate-to-gdp.html The PIC/S Committee met on May 30, 2011. The Members discussed amongs others the possibility of extending PIC/S’ mandate to GDP, which is largely supported, as there is a growing number of serious problems encountered during the inspection of the supply chain.

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Sun, 12 Jun 2011 22:00:00 +0000
<![CDATA[WHO: GMP for blood establishments]]> http://gmpupdate.swhosting6.de/en/gmp-news/gmp-aktuell/who-gmp-good-manufacturing-practices-blood-establishments.html The World Health Organization (WHO) recently published a revised GMP Guideline for blood establishments. The document is part of the WHO Technical Report Series, No. 961.

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Wed, 08 Jun 2011 22:00:00 +0000
<![CDATA[EU: EudraLex new release]]> http://gmpupdate.swhosting6.de/en/gmp-news/gmp-aktuell/EU-eudralex-new-release-V25-june-2011-gmp.html The European Commission (EC) has released a new version of the EudraLex database. Now, you can consult the whole Pharmaceutical Legislation (Human and Veterinary) with an integrated search engine.

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Sun, 05 Jun 2011 22:00:00 +0000
<![CDATA[TGAs Risk Management Approach]]> http://gmpupdate.swhosting6.de/en/gmp-news/gmp-aktuell/tga-risk-management-approach.html The Australian TGA (Therapeutic Goods Adminstration) adopts a risk management approach to regulating therapeutic goods.

mehr]]>
Thu, 02 Jun 2011 22:00:00 +0000
<![CDATA[FDA: Process Validation - A GMP Lifecycle Approach]]> http://gmpupdate.swhosting6.de/en/gmp-news/gmp-aktuell/process-validation-lifecycle-approach-fda.html FDA published a presentation of her Senior Policy Advisor Grace E. McNally concerning the Lifecycle Approach in the context of Process Validation.

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Tue, 31 May 2011 22:00:00 +0000
<![CDATA[EU adopts measures against falsified medicines]]> http://gmpupdate.swhosting6.de/en/gmp-news/gmp-aktuell/eu-adopts-measures-against-falsified-medicines.html On May 27, 2011, the EU Council formally adopted new legislation aimed at protecting patients against the rising threat of falsified medicines.

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Sun, 29 May 2011 22:00:00 +0000
<![CDATA[FDA: New, revised and withdrawn CDER Guidances]]> http://gmpupdate.swhosting6.de/en/gmp-news/gmp-aktuell/fda-new-revised-withdrawn-cder-guidances.html FDAs Center for Drug Evaluation and Reseach (CDER) regularly publishes a list of new, revised and wihtdrawn guidances.

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Sun, 22 May 2011 22:00:00 +0000
<![CDATA[HC:New Annex 4 to cGMP (GUI-0012)]]> http://gmpupdate.swhosting6.de/en/gmp-news/gmp-aktuell/4-annex-new-cgmp-health-canada.html On May 13, 2011 the Canadian food and drug autority Health Canada (HC) issued  the Guidance Document Annex 4 to the Current Edition of the Good Manufacturing Practices Guidelines - Veterinary Drugs (GUI-0012).

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Mon, 16 May 2011 22:00:00 +0000
<![CDATA[EC: Revised Annex 14 published]]> http://gmpupdate.swhosting6.de/en/gmp-news/gmp-aktuell/ec-revised-annex-14-published.html The European Commission (EC) published the revised Annex 14 "Manufacture of Products derived from Human Blood or Human Plasma (May 2011)" of the EU Guide to GMP.

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Tue, 10 May 2011 22:00:00 +0000
<![CDATA[GMP MANUAL Update No. 11]]> http://gmpupdate.swhosting6.de/en/gmp-news-updates/gmp-aktuell/11-update-gmp-manual.html What is new?

The recent update of the GMP MANUAL encompasses approx. 620 pages. Due to the fact that a lot of regulatory requirements have been updated and some new documents were published since the beginning of the year, this  update encompasses many new and updated chapters from the “GMP Regulation” Part of the MANUAL. Within the “GMP in Practice” Part, you will find a new and very comprehensive chapter on Medical Devices. With this chapter an important subject area has been introduced into the range of GMP related topics within the GMP MANUAL.

The contents of Update 11 are outlined below:

“GMP in Practice”

New Chapters:

  • Chapter 23: Medical Devices

Updated Chapters:

  • Chapter 7: Process Validation
    • 7.A: Official Requirements

“GMP Regulations”

New Chapters:

  • Chapter C: EU Directives and Guidelines
    • C.8: EU GMP Guide, Part III
  • Chapter D: USA: CFR and FDA Guidelines
    • D.17: Pre-Approval Inspections
  • Chapter F: PIC/S Guidelines
    • F.8: PIC/S PI 032-2: Recommendation GMP Annex 1 Revision 2008, Interpretation of Most Important Changes for the Manufacture of Sterile Medicinal Products

Updated Chapters:

  • Chapter C: EU Directives and Guidelines
    • C.1 EU GMP Guide: Introduction
    • C.4: Part I Basic Requirements for Medicinal Products
    • C.6.11: Annex 11 Computerized Systems
  • Chapter D: USA: CFR and FDA Guidelines
    • D.2: Guidance for Industry: Process Validation: General Principles and Practices
  • Chapter E: ICH Guidelines
    • E.3.C: ICH Q3C(R5) Guideline for residual solvents
  • Chapter F: PIC/S Guidelines
    • F.5: PIC/S PE 008-4 Explanatory notes for Industry on the preparation of a Site Master File
mehr]]>
Mon, 09 May 2011 22:00:00 +0000
<![CDATA[FDA: Periodic Review of Regulations]]> http://gmpupdate.swhosting6.de/en/gmp-news/gmp-aktuell/periodic-review-existing-regulations-fda.html The Food and Drug Administration (FDA) is conducting a review of its existing regulations to determine, whether they can be made more effective and to take advantage of and support advances in innovation.

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Sun, 08 May 2011 22:00:00 +0000
<![CDATA[EMA: Active Substance Manufacturers and GMP Compliance]]> http://gmpupdate.swhosting6.de/en/gmp-news/gmp-aktuell/ema-active-substance-manufacturers-gmp-compliance.html "How can GMP Compliance for Manufacturers of Active Substances be demonstrated?" asked the European Medicines Agency (EMA) recently.

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Mon, 02 May 2011 22:00:00 +0000
<![CDATA[PIC/S cGMP-Publications]]> http://gmpupdate.swhosting6.de/en/gmp-news/gmp-aktuell/pics-cgmp-publications.html Did you know? The Pharmaceutical Inspection Cooperation Scheme (PIC/S) provides important cGMP-Publications. You can download them for free from the PIC/S website.

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Sun, 01 May 2011 22:00:00 +0000
<![CDATA[India: New Guideline (CDSCO)]]> http://gmpupdate.swhosting6.de/en/gmp-news/gmp-aktuell/india-new-guideline-cdsco.html Indias Central Drugs Standard Control Organization (CDSCO) published recently a document concerning Requirements and Guidelines for permission and Import and/ or manufacture of New Drugs.

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Wed, 27 Apr 2011 22:00:00 +0000
<![CDATA[EMA: Q&A Annex 11 Computerised Systems]]> http://gmpupdate.swhosting6.de/en/gmp-news/gmp-aktuell/ema-annex-11-computerised-systems.html Annex 11 of the EU GMP guide provides information concerning Computerised Systems. EMA recently published Qustions & Answers with supplementary requirements.

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Sun, 17 Apr 2011 22:00:00 +0000
<![CDATA[EU: Revision Chapt. 8 EU GMP Guide]]> http://gmpupdate.swhosting6.de/en/gmp-news/gmp-aktuell/eu-pharma-revision-chapter-8-eu-gmp-guide-concept-paper.html The EC (European Commission) has initiated a revision of chapter 8 EU GMP Guide. The revision introduces risk-based concepts and provides more effective investigations and CAPA.

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Tue, 12 Apr 2011 22:00:00 +0000
<![CDATA[EMA closes PIM project]]> http://gmpupdate.swhosting6.de/en/gmp-news/gmp-aktuell/ema-closes-pim-project.html The European Medicines Agency (EMA) announced the closure of the PIM project on march 28, 2011.

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Sun, 03 Apr 2011 22:00:00 +0000
<![CDATA[Analysis: FDA Obtains Full PIC/S Membership in 2011]]> http://gmpupdate.swhosting6.de/en/gmp-news/gmp-aktuell/analysis-fda-obtains-full-pics-membership-2011.html This will be an exciting year for harmonizing international GMP standards. Last November, during the PIC/S Conference in Kuala Lumpur (Malaysia) the PIC/S Committee Meeting invited FDA to become a full member. Pharmaceutical Technology recently published a broad analysis of this expansion, written by Thomas Peither.

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Sun, 27 Mar 2011 22:00:00 +0000
<![CDATA[China meets WHO standards]]> http://gmpupdate.swhosting6.de/en/gmp-news/gmp-aktuell/china-meets-international-standards-who.html Chinese national regulatory authority meets international standards. This conclusion was drawn by an expert group after a comprehensive review of the national regulatory authority of China, the State Food and Drug Administration (SFDA), and affiliated institutions. They meet WHO indicators for a functional vaccine regulatory system.

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Mon, 21 Mar 2011 23:00:00 +0000
<![CDATA[Canada: GMP-Guidelines 2009 (Vers 2) online]]> http://gmpupdate.swhosting6.de/en/gmp-news/gmp-aktuell/canada-gmp-guidelines-2009-version-2-online.html On March 4, 2011 the canadian Health Products and Food Branch Inspectorate issued the finalized "Good Manufacturing Practices (GMP) Guidelines 2009 Edition, Version 2 (GUI-0001)".

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Sun, 20 Mar 2011 23:00:00 +0000
<![CDATA[2011 Work Plan for GMP/GDP Inspectors Working Group]]> http://gmpupdate.swhosting6.de/en/gmp-news/gmp-aktuell/2011-work-plan-gmp-gdp-inspectors-working-group.html Recently EMAs GMP/GDP Inspectors Working Group published the 2011 inspections plan. The Inspectors Working Group explains the 2011 GMP & GDP topics.

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Thu, 17 Mar 2011 23:00:00 +0000
<![CDATA[FDA: New & Revised Draft Guidances 2011]]> http://gmpupdate.swhosting6.de/en/gmp-news/gmp-aktuell/fda-new-revised-draft-guidances-2011.html FDAs Centre for Drug Evaluation and Research (CDER) recently informed about new and revised guidance documents it is planning to release in 2011.

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Thu, 10 Mar 2011 23:00:00 +0000
<![CDATA[WHO Report: Inspections of API Manufacturers]]> http://gmpupdate.swhosting6.de/en/gmp-news/gmp-aktuell/who-report-inspections-api-manufacturers.html Recently the WHO (World Health Organization) issued the first "Pharmaceuticals Newsletter" in 2011. It contains an interesting Report on WHO Inspection Activites of API (Active Pharmaceutical Ingredients) Manufacturers.

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Mon, 07 Mar 2011 23:00:00 +0000
<![CDATA[FDA: Applying ICH Q8(R2), Q9, and Q10 Principles]]> http://gmpupdate.swhosting6.de/en/gmp-news/gmp-aktuell/fda-applying-ich-q8-q9-q10-principles.html On Februar 8, 2011 the U.S. FDA's Office of Pharmaceutical Science informed about the new document "Applying ICH Q8(R2), Q9, and Q10 Principles to CMC Review".

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Mon, 28 Feb 2011 23:00:00 +0000
<![CDATA[China: New GMPs published]]> http://gmpupdate.swhosting6.de/en/gmp-news/gmp-aktuell/china-sfda-new-gmps-published.html China's SFDA (State Food and Drug Administration) published the revised 2010 edition of the Good Manufacturing Practice for Pharmaceutical Products. This document will come into effect as of March 1, 2011.

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Wed, 23 Feb 2011 23:00:00 +0000
<![CDATA[ICH Q9 & Q10: Part III EU GMP Guide (EMA)]]> http://gmpupdate.swhosting6.de/en/gmp-news/gmp-aktuell/ich-q9-q10-part-3-eu-gmp-guide-ema.html The new Part III of the EU GMP Guide becomes speedily filled with information. EMA (European Medicines Agency) announced recently, that they decided to add the ICH Q 9 and Q10 Guidelines to Part III.

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Sun, 13 Feb 2011 23:00:00 +0000
<![CDATA[New Part III EU GMP published (EC)]]> http://gmpupdate.swhosting6.de/en/gmp-news/gmp-aktuell/new-part-3-eu-gmp-published-ec.html On Feburary 7, 2011 the European Commission (EC) published the new Part III "GMP related Documents" of the EU GMP Guide.

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Tue, 08 Feb 2011 23:00:00 +0000
<![CDATA[Revised Chapter 4 EU GMP Guide published]]> http://gmpupdate.swhosting6.de/en/gmp-news/gmp-aktuell/revised-chapter-4-eu-gmp-guide-published.html On January 12, 2011 the European Commission published the revised Chapter 4 "Documentation" of the EU GMP Guide. The document will come into operation on June 30, 2011.

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Sun, 06 Feb 2011 23:00:00 +0000
<![CDATA[Process Validation Guidance published!]]> http://gmpupdate.swhosting6.de/en/gmp-news/gmp-aktuell/process-validation-guidance-published.html U.S. FDA announced the revised Guidance for Industry "Process Validation" to be published until end of 2010. Yesterday, on January 24, 2011 they finaly issued the document.

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Mon, 24 Jan 2011 23:00:00 +0000
<![CDATA[EU published reviesed Annex 11]]> http://gmpupdate.swhosting6.de/en/gmp-news/gmp-aktuell/EU-published-revised-annex-11-computerised-systems.html The revised Annex 11 "Computerised Systems" is online available at the European Commission website.

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Wed, 12 Jan 2011 23:00:00 +0000
<![CDATA[PIC/S: Revised Site Master File]]> http://gmpupdate.swhosting6.de/en/gmp-news/gmp-aktuell/revised-site-master-file-pics.html At its meeting in Kuala Lumpur in November 2010, the PIC/S Committee has adopted the revision of the "Explanatory Notes for Industry on the Preparation of a Site Master File". The new document comes in force on January 01, 2011.

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Mon, 10 Jan 2011 23:00:00 +0000
<![CDATA[EDQM Strengthens Intern. Collaboration]]> http://gmpupdate.swhosting6.de/en/gmp-news/gmp-aktuell/edqm-strengthens-international-collaboration.html The European Directorate for the Quality of Medicines & Healthcare (EDQM, Council of Europe) is strengthening its collaboration with renowned international organisations in the field of medicines by signing Memorandums of Understanding (MoU) with the National Institute of Food and Drug Safety Evaluation (NIFDS), Korea Food and Drug Administration, and the Chinese National Institute of Food and Drug Control (NIFDC), respectively.

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Tue, 14 Dec 2010 23:00:00 +0000
<![CDATA[FDA Process Validation Guidance 2010]]> http://gmpupdate.swhosting6.de/en/gmp-news/gmp-aktuell/fda-process-validation-guidance-2010.html More than 2 years after the publication of the draft guidance it seems that FDA will publish the final version of this important guidance until end of the year.

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Sun, 12 Dec 2010 23:00:00 +0000
<![CDATA[Revision of Chapter 6 "Quality Control" of the EU GMP Guide (EMA) ]]> http://gmpupdate.swhosting6.de/en/gmp-news/gmp-aktuell/revision-chapter-6-quality-control-eu-gmp-guide-ema.html The EMA (European Medicines Agency) will be revising the chapter 6 "Quality control" of the EU GMP Guide. The topic of OOS (Out Of Specification) results commonly found in test method validations at contract quality control laboratories needs to be clarified in consideration of globalized transfer of analytical methods.

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Sun, 05 Dec 2010 23:00:00 +0000
<![CDATA[Chapter 7 EU GMP Guideline: Public Consultation (EC)]]> http://gmpupdate.swhosting6.de/en/gmp-news/gmp-aktuell/chapter-7-eu-gmp-guideline-public-consultation-ec.html The Revisions concerning Chapter 7 "Contract Manufacture and Analysis" are in progress. On November 9, 2010 the ECs Directorate General for Health and Consumer Affairs (DG SANCO) launched a public consultation.

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Mon, 29 Nov 2010 23:00:00 +0000
<![CDATA[ICH: Further Expansion to Non-ICH Regions]]> http://gmpupdate.swhosting6.de/en/gmp-news/gmp-aktuell/ich-further-expansion-non-ich-regions.html The International Conference on Harmonisation (ICH) Steering Committee (SC) and its working groups met in Fukuoka, Japan from 6 – 11 November 2010. This meeting marked the 20 year anniversary of the international harmonization initiative.

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Thu, 25 Nov 2010 23:00:00 +0000
<![CDATA[Chapter 5 EU GMP Guideline: Public Consultation (EC)]]> http://gmpupdate.swhosting6.de/en/gmp-news/gmp-aktuell/eu-gmp-guideline-chapter-5-public-consultation-ec.html On November 19, 2010 the EC's DG Sanco (Directorate General for Health and Consumer Affairs) launched a public consultation concerning the revised Chapter 5 "Production" of the EU GMP Guideline. This is an important public consultation, because this chapter affects most of the enterprises dealing with the GMP topic.

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Sun, 21 Nov 2010 23:00:00 +0000
<![CDATA[PIC/S: USA and Ukraine new Members]]> http://gmpupdate.swhosting6.de/en/gmp-news/gmp-aktuell/pics-usa-ukraine-new-members-january-2011.html Now it is official: USA and Ukraine join PIC/S starting January 1, 2011. The Committee invited the US Food and Drug Administration (FDA) and the Ukraine’s State Inspectorate for Quality Control of Medicines (SIQCM) to join the Scheme. The Decision was made on the PIC/S (Pharmaceutical Inspection Co-operation Scheme) Meeting in Kuala Lumpur on November 8 - 9, 2010.

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Wed, 17 Nov 2010 23:00:00 +0000
<![CDATA[GMP MANUAL: Update 10]]> http://gmpupdate.swhosting6.de/en/gmp-news/gmp-aktuell/gmp-manual-update-10.html GMP topics are always changing, so are our reference books, too. During the last months we updated the GMP MANUAL, so that you now receive our latest Update 10. With our Updates your GMP MANUAL stays futhermore the most powerfull GMP Reference Book in the world!

You don't own the GMP MANUAL by now? Order now your copy including the latest update!

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Mon, 08 Nov 2010 23:00:00 +0000
<![CDATA[New Q&A Documents for Veterinary Medicinal Products (EMA)]]> http://gmpupdate.swhosting6.de/en/gmp-news/gmp-aktuell/new-q-a-documents-veterinary-medicinal-products-ema.html EMAs joint CHMP/CVMP Quality Working Party recently published new Q&A documents concerning Veterinary Medicinal Products.

The documents provide the EEA harmonised position on issues that can be subject to different interpretation or require clarification, typically arising from discussions or correspondence during assessment procedures.

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Sun, 07 Nov 2010 23:00:00 +0000
<![CDATA[Prequalification of APIs (WHO)]]> http://gmpupdate.swhosting6.de/en/gmp-news/gmp-aktuell/prequalification-api-who.html The WHO Prequalification of Medicines Programme (PQP) will pilot prequalification of selected active pharmaceutical ingredients (APIs) for products for treating HIV and related diseases, for antimalarial medicinal products and for anti-tuberculosis products, as of 21 October 2010.

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Mon, 01 Nov 2010 23:00:00 +0000
<![CDATA[New Australian Guideline (TGA)]]> http://gmpupdate.swhosting6.de/en/gmp-news/gmp-aktuell/new-australian-guideline-tga.html The Australian Therapeutic Goods Administration (TGA) has revised it's "Guidance on Clearance of Products Manufactured Overseas". The draft has been published in September 2010. It will replace TGA's 2008 Guidance. Deadline for comments is November 15, 2010.

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Tue, 26 Oct 2010 22:00:00 +0000
<![CDATA[EMA: New fees for marketing authorisation applications ]]> http://gmpupdate.swhosting6.de/en/gmp-news/gmp-aktuell/ema-new-fees-marketing-authorisation-applications .html The European Medicines Agency (EMA) has changed its rules on fees payable to the Agency. The new fee rules came into operation on October, 7 2010.

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Mon, 18 Oct 2010 22:00:00 +0000
<![CDATA[FDA-PIC/S: Follow-up visit]]> http://gmpupdate.swhosting6.de/en/gmp-news/gmp-aktuell/fda-pics-follow-up-visit-gmp.html The accession of US FDA to PIC/S as from 2011 has taken another step forward. As PIC/S announced at the end of September 2010, the follow-up visit at the FDA Headquaters in Maryland was satisfying.

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Sun, 17 Oct 2010 22:00:00 +0000
<![CDATA[FDA Medical Devices Inspection Database]]> http://gmpupdate.swhosting6.de/en/gmp-news/gmp-aktuell/gmp-fda-inspection-database-medical-devices.html On October 1, 2010 FDAs CDRH (Center for Devices and Radiological Health) launched the ‘CDRH Inspections Database’. The database provides information about medical device inspections that were the responsibility of CDRH from 2008.

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Wed, 13 Oct 2010 22:00:00 +0000
<![CDATA[GMP MANUAL Update No. 10]]> http://gmpupdate.swhosting6.de/en/gmp-news-updates/gmp-aktuell/10-gmp-manual-update.html available since November 2010

What is new?

The recent update of the GMP MANUAL encompasses approx. 530 pages for the printed version. Additionally, another 250 pages are provided for the electronic media (CD ROM and Online version).
The contents of Update 10 are outlined below:

“GMP in Practice”

Updated Chapters:

  • Chapter 17: Contractors and Suppliers (new title):
    • 17.A Contract Manufacture
    • 17.B Contract Analysis
  • Chapter 21: Active and Inactive Ingredients (new title):
    • 21.A GMP for Active Pharmaceutical Ingredients (APIs)

New Chapters:

  • Chapter 17: Contractors and Suppliers (new title):
    • 17.C Suppliers
    • 17.D References
  • Chapter 18: Inspections
    • 18.I References
  • Chapter 21: Active and Inactive Ingredients (new title):
    • 21.B GMP for APIs – considerations on special topics
    • 21.C Excipients
    • 21.D References

“GMP Regulations”

Updated Chapters:

  • Chapter C: EU Directives and Guidelines (new title)
    • C.5: Part II – Basic Requirements for Active Substances used as Starting Materials

New Chapters:

  • Chapter C: EU Directives and Guidelines (new title)
    • C.10 Compilation of Community Procedures on Inspections and Exchange of Information: Procedure for dealing with serious GMP non-compliance for voiding/suspension of CEPS thus requiring coordinated administrative action
  • Chapter G: GMP of other Regions
    • G.1.3 WHO Technical Report Annex 5: Good Distribution Practice
    • G.2 Health Canada Good Manufacturing Practices (GMP) Guidelines, 2009 Edition
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Mon, 04 Oct 2010 22:00:00 +0000
<![CDATA[PDA Europe Parenterals Conference 2010]]> http://gmpupdate.swhosting6.de/en/gmp-news/gmp-aktuell/pda-europe-parenterals-conference-2010.html The PDA Europe Parenterals Conference 2010 held in Berlin, Germany, on 26-28 October is an outstanding opportunity to learn from inspectors and their views on very important GMP topics.

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Mon, 27 Sep 2010 22:00:00 +0000
<![CDATA[EMA & FDA confidentiality arrangements ]]> The European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA) have extended their confidentiality arrangements related to medicinal products for human and veterinary use, following the positive experience gained since the initial arrangements were signed in September 2003. This cooperation will now continue indefinitely without the need for further renewal.

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Thu, 23 Sep 2010 22:00:00 +0000
<![CDATA[NEW: Checklist GMP Inspections]]> http://gmpupdate.swhosting6.de/en/gmp-news/gmp-aktuell/new:_checklist-gmp-inspections.html The first edition of the Checklist GMP Inspections is now available. This convenient document contains 650 questions typically asked during inspections, arranged by subject-matter.

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Mon, 20 Sep 2010 22:00:00 +0000
<![CDATA[EMA: EU Annex 6: New Q&A]]> http://gmpupdate.swhosting6.de/en/gmp-news/gmp-aktuell/eu-annex-6-ema.html EMA published recently for the Annex 6 of the EU GMP Guide "Manufacture of Medicinal Gases" a new list of questions and answers.

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Tue, 14 Sep 2010 22:00:00 +0000
<![CDATA[New ICH E7 Q&A Guideline]]> http://gmpupdate.swhosting6.de/en/gmp-news/gmp-aktuell/new-ich-e7-guideline.html ICH IWG E7published the finalised Q&A Guideline "Studies in Support of Special Populations: Geriatrics". This is an outcome of the ICH 2010 Meeting held in Tallin (Estonia) in June.

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Tue, 07 Sep 2010 22:00:00 +0000
<![CDATA[Validation Procedures (Vol 2) now available!]]> http://gmpupdate.swhosting6.de/en/gmp-news/gmp-aktuell/.html The second publication in the new GMP MANUAL series deals with the topic "Validation Procedures" and is now available. It contains all important GMP MANUAL chapters concerning this topic.

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Tue, 31 Aug 2010 22:00:00 +0000
<![CDATA[Summer Special: 30% discount]]> http://gmpupdate.swhosting6.de/en/gmp-news/gmp-aktuell/.html Until August 31, 2010 we offer you a  summer discount of 30% for selected products from our GMP MANUAL series. By making use of this offer, you can save up to € 200 or $ 298!

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Sun, 22 Aug 2010 22:00:00 +0000
<![CDATA[Guidance Holding and Distribution (FDA)]]> http://gmpupdate.swhosting6.de/en/gmp-news/gmp-aktuell/.html At the beginning of August FDA published the list "Questions and Answers on Current Good Manufacturing Practices, Good Guidance Practices, Level 2 Guidance Holding and Distribution". The document provides information about the recall of human drugs and details about the agency’s authority and manufacturers’ responsibilities.

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Wed, 18 Aug 2010 22:00:00 +0000
<![CDATA[EMA/FDA:Joint GMP Inspections]]> http://gmpupdate.swhosting6.de/en/gmp-news/gmp-aktuell/EMA-FDA-Joint-GMP-Inspection-Pilot-Programme.html End of July 2010 FDA and EMA published a common document describing their joint GMP Inspection Pilot Programme.

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Sat, 14 Aug 2010 22:00:00 +0000
<![CDATA[WHO: New Technical Report published]]> http://gmpupdate.swhosting6.de/en/gmp-news/gmp-aktuell/.html WHO (World Health Organization) recently published the latest issue of the 957 WHO Technical Report Series concerning information provided by the "WHO Expert Committee on specifications for pharmaceutical preparations". This publication makes available the findings of several international groups of experts that provide WHO with the latest scientific and technical advice.

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Tue, 03 Aug 2010 22:00:00 +0000
<![CDATA[Chinese GMPs]]> http://gmpupdate.swhosting6.de/en/gmp-news/gmp-aktuell/chinese-gmp-sfda.html Asian Markets are becoming increasingly important for manufacturers in Europe and the U.S. The knowledge about the regulations in Asia is a key information for global engaged companies.

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Tue, 27 Jul 2010 22:00:00 +0000
<![CDATA[EU: InVitro Diagnostic Medical Devices Directive]]> http://gmpupdate.swhosting6.de/en/gmp-news/gmp-aktuell/europe-invitro-diagnostic-medical-devices-directive.html The European Commission (EC) started a public consultation on the technical aspects of the revision of the Directive on InVitro Diagnostic (IVD) Medical Devices (98/79/EC).

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Mon, 26 Jul 2010 22:00:00 +0000
<![CDATA[FDA: Focus on Part 11]]> http://gmpupdate.swhosting6.de/en/gmp-news/gmp-aktuell/fda-focus-on-21-cfr-11-part-11.html The FDA recently announced that they will focus on the issues of 21 CFR 11 (Part 11) by conducting a series of inspections. They aim to evaluate industry’s compliance and understanding of Part 11. Stress will be layed on the enforcement discretion described in the August 2003 "Part 11, Electronic Records; Electronic Signatures — Scope and Application" guidance.

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Sun, 25 Jul 2010 22:00:00 +0000
<![CDATA[Meet us at PDA/FDA Conference]]> http://gmpupdate.swhosting6.de/en/gmp-news/gmp-aktuell/2010-pda-fda-joint-regulatory-conference.html Meet us at the 2010 PDA/ FDA Joint Regulatory Conference which will take place September 13-15 in Washington D.C. This year's conference theme is "The new Paradigm: Quality and Compliance in Merging and Emerging Cultures".

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Thu, 22 Jul 2010 22:00:00 +0000
<![CDATA[ICH: New Released Guidelines]]> http://gmpupdate.swhosting6.de/en/gmp-news/gmp-aktuell/ich-newly-released-guidelines.html ICH (International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use) published four newly released Guidelines that were signed in Tallinn, Estonia, June 5-10, 2010. The Documents are now available on the ICH website.

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Mon, 19 Jul 2010 22:00:00 +0000
<![CDATA[EU GMP Part II comes in operation]]> http://gmpupdate.swhosting6.de/en/gmp-news/gmp-aktuell/eu-gmp-part-ii-comes-in-operation.html Revised part II of EU GMP Guideline "Basic Requirements for Active Substances used as Starting Materials" will come into operation by July 31, 2010.

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Sun, 18 Jul 2010 22:00:00 +0000
<![CDATA[EU GMP: Annex 6+13 come into operation ]]> http://gmpupdate.swhosting6.de/en/gmp-news/gmp-aktuell/eu-gmp-annex-6-13-come-into-operation.html The European Commission has published the revised annexes 6 and 13 of the EU GMP Guideline some months ago. They come into operation on  July 31, 2010.

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Wed, 14 Jul 2010 22:00:00 +0000
<![CDATA[ICH: Implementing Quality Paradigm]]> http://gmpupdate.swhosting6.de/en/gmp-news/gmp-aktuell/ich-implementing-quality-paradigm.html New GMP information about ICH meeting in Tallinn describes recent developments for the pharmaceutical industry.

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Sun, 11 Jul 2010 22:00:00 +0000
<![CDATA[PIC/S: APIs Increasing Importance]]> http://gmpupdate.swhosting6.de/en/gmp-news/gmp-aktuell/pic-s-apis-increasing-importance.html On June 22, 2010 PIC/S announced that they have been invited by the European Commission to participate in an initiative for enhanced international co-operation in the field of APIs.

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Wed, 07 Jul 2010 22:00:00 +0000
<![CDATA[PIC/S Commitee Meeting]]> http://gmpupdate.swhosting6.de/en/gmp-news/gmp-aktuell/pic-s-commitee-meeting.html The PIC/S Committee met in Geneva (Switzerland) on 19-20 May 2010.

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Thu, 24 Jun 2010 22:00:00 +0000
<![CDATA[EMA: Pilot Batch Size - Process Control]]> http://gmpupdate.swhosting6.de/en/gmp-news/gmp-aktuell/ema-pilot-batch-size-process-control.html "When validating a manufacturing process, if a common bulk is used to manufacture a series of products, how should the pilot batch size be decided upon?" The answer to this question is provided by EMAs Quality Work Party in their Questions & Answers List.

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Tue, 22 Jun 2010 22:00:00 +0000
<![CDATA[EMA: Benefit Risk Project]]> http://gmpupdate.swhosting6.de/en/gmp-news/gmp-aktuell/ema-benefit-risk-project.html Recently EMA published a summary of its benefit-risk assessment efforts for centralised procedure products.

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Sun, 20 Jun 2010 22:00:00 +0000
<![CDATA[Draft Guidance Devices (FDA) ]]> http://gmpupdate.swhosting6.de/en/gmp-news/gmp-aktuell/draft-guidance-devices-fda-.html By end of April 2010 FDA issued the draft guidance entitled  "FDA and Industry Procedures for Section 513(g) Requests for Information under the Federal Food, Drug, and Cosmetic Act" concerning devices.

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Tue, 15 Jun 2010 22:00:00 +0000
<![CDATA[Q8, Q9, Q10 Questions and Answers (FDA)]]> http://gmpupdate.swhosting6.de/en/gmp-news/gmp-aktuell/q8-q9-q10-questions-and-answers-fda.html This FDA Guidance for Industry aims to clarify key issues concerning Q8, Q9 and Q10.

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Mon, 14 Jun 2010 22:00:00 +0000
<![CDATA[EMA: Biopharmaceutical and Bioanalytical Data]]> http://gmpupdate.swhosting6.de/en/gmp-news/gmp-aktuell/ema-biopharmaceutical-and-bioanalytical-data.html Recently EMA published the "Concept paper on the Need to Develop an Appendix to the Guideline on Bioequivalence Regarding the Presentation of Biopharmaceutical and Bioanalytical Data in Application Dossiers".

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Tue, 08 Jun 2010 22:00:00 +0000
<![CDATA[GMP MANUAL Update No. 09]]> http://gmpupdate.swhosting6.de/en/gmp-news-updates/gmp-aktuell/gmp-manual-update-no-09.html What is new?

The recent update of the GMP MANUAL encompasses approx. 660 pages for the
printed version. We have outlined the contents of Update 09 below:

“GMP in Practice”

Updated Chapters:

  • Chapter 11: Production
  • 11.O References
  • Chapter 18: Inspections:
  • 18.H Questionnaire for preparing GMP-inspections
  • Chapter 20: Continual Improvement Methods:
  • 20.E References

New Chapters:

  • Chapter 1: Pharmaceutical Quality System:
  • Chapter 11: Production
  • 11.N Transportation
  • Chapter 20: Continual Improvement Methods:
  • 20.C Statistical Process Control
  • 20.D Process Analytical Technology

“GMP Regulations”

Updated Chapters:

  • Chapter C: EU GMP Guide
  • C.6: Annex 1 – Annex 20
  • Chapter E: ICH-Guidelines
  • E.8: ICH Q8 (R2)

New Chapters:

  • Chapter E: ICH-Guidelines
  • E.10.1: Quality Implementation Working Group on Q8, Q9 and Q10: Questions & Answers
  • Chapter F: PIC/S-Guidelines
  • F.7: PI 028-1 Aide-mémoire GMP Inspection related to Packaging
mehr]]>
Tue, 25 May 2010 22:00:00 +0000
<![CDATA[Pharm. Eu. 7th Edition (EDQM)]]> http://gmpupdate.swhosting6.de/en/gmp-news/gmp-aktuell/pharm-eu-7th-edition-edqm.html The 7th Edition of the European Pharmacopeia will be released by the EDQM this year. There will be changes concerning the electronic version.

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Wed, 19 May 2010 22:00:00 +0000
<![CDATA[EMA: Training Manual]]> http://gmpupdate.swhosting6.de/en/gmp-news/gmp-aktuell/ema-training-manual.html EMA offers an online training manual concerning  the topic  "Review of European Medicines Agency documents addressed to the general public by patients and consumers".

mehr]]>
Mon, 10 May 2010 22:00:00 +0000
<![CDATA[Draft Guideline: Evaluation of Medicinal Products]]> http://gmpupdate.swhosting6.de/en/gmp-news/gmp-aktuell/draft-guideline-evaluation-of-medicinal-products.html EMAs Committee for Medicinal Products for Human Use (CHMP) published a draft guideline concering the "Evaluation of Medicinal Products indicated for Treatment of Bacterial Infections".

mehr]]>
Sun, 09 May 2010 22:00:00 +0000
<![CDATA[EU GMP Annex 2, Public Consultation]]> http://gmpupdate.swhosting6.de/en/gmp-news/gmp-aktuell/eu-gmp-annex-2-public-consultation.html The European Commission published the draft of Annex 2 "Manufacture of Biological Medicinal Substances and Products for Human Use" of the EU GMP Guide for a second public consultation.

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Wed, 05 May 2010 22:00:00 +0000
<![CDATA[Counterfeit of medicinal products (Council of Europe)]]> http://gmpupdate.swhosting6.de/en/gmp-news/gmp-aktuell/counterfeit-of-medicinal-products-council-of-europe.html On April 15-16, 2010, more than 140 participants from around 40 states, international organisations and institutions from around the world met in Basel (Switzerland) to discuss the practical implementation of the MEDICRIME Convention.

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Mon, 26 Apr 2010 22:00:00 +0000
<![CDATA[EU Databank for Medical Devices]]> http://gmpupdate.swhosting6.de/en/gmp-news/gmp-aktuell/eu-databank-for-medical-devices.html On April 19, 2010, the European Commission informed, that they will oblige all EU countries to use the European Databank For Medical Devices (EUDAMED) starting on May 2011.

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Sun, 25 Apr 2010 22:00:00 +0000
<![CDATA[Heparin Monographs (Pharm.Eur.) ]]> http://gmpupdate.swhosting6.de/en/gmp-news/gmp-aktuell/heparin-monographs-pharmeur-.html On April 20, 2010 EMA published new information on Heparin Monographs according to the European Pharmacopoeia.

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Thu, 22 Apr 2010 22:00:00 +0000
<![CDATA[FDA: Improvement of Guidance Development Process]]> http://gmpupdate.swhosting6.de/en/gmp-news/gmp-aktuell/fda-improvement-of-guidance-development-process.html FDAs Task Force concering the Transparency Initiative is collecting information on how to improve FDA's transparency to regulated industry. They held three listening sesions with members of regulated industry during January 2010.

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Wed, 21 Apr 2010 22:00:00 +0000
<![CDATA[FDA: Q4B, Annex 10]]> http://gmpupdate.swhosting6.de/en/gmp-news/gmp-aktuell/fda-q4b-annex-10.html On April 9, 2010 US FDA published Annex 10 "Polyacrylamide Gel Electrophoresis - General Chapter"  of the Guidance for Industry "Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions".

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Mon, 19 Apr 2010 22:00:00 +0000
<![CDATA[Water for Injection (EDQM)]]> http://gmpupdate.swhosting6.de/en/gmp-news/gmp-aktuell/water-for-injection-edqm.html On April 1, 2010 European Pharmacopoeia Commission published information concerning a survey to possible changes regarding Water for Injection.

Currently, the European Pharmacopoeia only allows distillation for the production of Water for Injection (WFI). Renewed discussions have taken place at the end of 2009 amongst regulators in Europe on the suitability of using Reverse Osmosis (RO) to produce WFI. Concerns from regulators regarding the use of RO for the production of WFI had previously been expressed in a reflection paper issued by the Joint CHMP/CVMP Quality Working Party in early 2008.

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Sun, 18 Apr 2010 22:00:00 +0000
<![CDATA[Anti-Counterfeit (EFPIA)]]> http://gmpupdate.swhosting6.de/en/gmp-news/gmp-aktuell/anti-counterfeit-efpia.html EFPIA (European Federation of Pharmaceutical Industry and Associations) published the results of their product verification system pilot project on April 12, 2010. The pilot successfully demonstrated a product verification system at the point of drug-dispense of a swedish pharmacy chain. The system is based on a 2-D data matrix code.

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Thu, 15 Apr 2010 22:00:00 +0000
<![CDATA["New" Heparin (USP)]]> http://gmpupdate.swhosting6.de/en/gmp-news/gmp-aktuell/new-heparin-usp.html On April 7, 2010 CDERs Division of Drug Information (DDI) published a Drug Information Update concerning the changes to the Heparin Sodium USP Monograph.

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Wed, 14 Apr 2010 22:00:00 +0000
<![CDATA[We have moved!]]> http://gmpupdate.swhosting6.de/en/gmp-news/gmp-aktuell/we-have-moved.html On 12 April 2010 we have relocated the Maas & Peither's German headquaters to a new address.

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Mon, 12 Apr 2010 22:00:00 +0000
<![CDATA[Q4B, Annex 7 & 9 (FDA)]]> http://gmpupdate.swhosting6.de/en/gmp-news/gmp-aktuell/q4b-annex-7-9-fda.html On April 2, 2010 FDA published the Annexes 7 "Dissolution Test General Chapter" and 9 "Tablet Friability General Chapter" to the Guidance for Industry "Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions"

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Tue, 06 Apr 2010 22:00:00 +0000
<![CDATA[EMA: Working Plan 2010 of QWP]]> http://gmpupdate.swhosting6.de/en/gmp-news/gmp-aktuell/ema-working-plan-2010-of-qwp.html EMA's Quality Working Party (QWP) has published its Work Plan for 2010.

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Mon, 05 Apr 2010 22:00:00 +0000
<![CDATA[Final Guidance: Standardized Numerical Identification]]> http://gmpupdate.swhosting6.de/en/gmp-news/gmp-aktuell/final-guidance-standardized-numerical-identification.html On March 26, 2010 FDA published the Final Guidance for Industry "Standards for Securing the Drug Supply Chain - Standardized Numerical Identification for Prescription Drug Packages".

This guidance is intended to address provisions set forth in Section 505D of the Federal Food, Drug, and Cosmetic Act (the Act) regarding development of standardized numerical identifiers (SNIs) for prescription drug packages. In this guidance, FDA is identifying package-level SNIs, as an initial step in FDA’s development and implementation of additional measures to secure the drug supply chain.

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Wed, 31 Mar 2010 22:00:00 +0000
<![CDATA[Database Release "QPSHARE"]]> http://gmpupdate.swhosting6.de/en/gmp-news/gmp-aktuell/database-release-qpshare.html On March 17, 2010 the QP Association announced that it released its database "QPSHARE". The new database allows QPs to increase the efficiency of their companies’ supplier qualification.

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Tue, 30 Mar 2010 22:00:00 +0000
<![CDATA[Process Validation: EMA Concept Paper]]> http://gmpupdate.swhosting6.de/en/gmp-news/gmp-aktuell/process-validation-ema-concept-paper.html EMA published some days ago the Concept Paper on the Revision of the Guideline on Process Validation. This concept paper aims to update the guideline on Process Validation; due to the development of new ICH guidelines Q8, Q9 and Q10, this guideline is being reviewed in order to implement the concepts highlighted in the ICH guidelines.

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Mon, 29 Mar 2010 22:00:00 +0000
<![CDATA[EMA Draft: Real Time Release Testing]]> http://gmpupdate.swhosting6.de/en/gmp-news/gmp-aktuell/ema-draft-real-time-release-testing.html EMAs Committee for Medicinal Products for Human Use (CHMP) has published the Draft "Guideline on Real Time Release Testing (formerly Guideline on Parametric Release)".

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Sun, 28 Mar 2010 22:00:00 +0000
<![CDATA[NEW: Free GMP Glossary]]> http://gmpupdate.swhosting6.de/en/gmp-news/gmp-aktuell/new-free-gmp-glossary.html The GMP Experts of Maas & Peither have published an Online GMP Glossary free of charge.

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Thu, 25 Mar 2010 23:00:00 +0000
<![CDATA[EDQM: Related Substances ]]> http://gmpupdate.swhosting6.de/en/gmp-news/gmp-aktuell/edqm-related-substances-.html As the requirements for related substances in Ph. Eur. monographs have been adapted in accordance with the principles of ICH Guideline Q3A(R2), there is a need for more appropriate format for quantitative purposes. The Chairs of EDQM's Chemical Groups have developed a model text to which new or revised monographs would be adapted.

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Wed, 24 Mar 2010 23:00:00 +0000
<![CDATA[FDA Webinar: Inspection Process]]> http://gmpupdate.swhosting6.de/en/gmp-news/gmp-aktuell/fda-webinar-inspection-process.html What kinds of products and facilities does the Food and Drug Administration (FDA) inspect? Who conducts these inspections? What do they look for?

On Thursday, March 25th, at 2 p.m. ET, the FDA will host a webinar that answers these questions and more. The featured speaker, Michael Rogers, Deputy Director, Office of Regional Operations, will discuss how FDA staff inspect domestic and foreign establishments, check shipments of imported product, and collect and test samples for signs of contamination.

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Sun, 21 Mar 2010 23:00:00 +0000
<![CDATA[FDA Draft on Adaptive Design CT]]> http://gmpupdate.swhosting6.de/en/gmp-news/gmp-aktuell/fda-draft-on-adaptive-design-ct.html FDA published a Draft Guidance on "Adaptive Design Clinical Trials for Drugs and Biologics" on Feburary 25, 2010.

This guidance provides sponsors and the review staff in the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER) at the Food and Drug Administration (FDA) with information regarding adaptive design clinical trials when used in drug development programs. This guidance gives advice on topics such as (1) what aspects of adaptive design trials (i.e., clinical, statistical, regulatory) call for special consideration, (2) when to interact with FDA while planning and conducting adaptive design studies, (3) what information to include in the adaptive design for FDA review, and (4) issues to consider in the evaluation of a completed adaptive design study. This guidance is intended to assist sponsors in planning and conducting adaptive design clinical studies, and to facilitate an efficient FDA review.

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Wed, 10 Mar 2010 23:00:00 +0000
<![CDATA[FDA: Cell-based Viral Vaccines]]> http://gmpupdate.swhosting6.de/en/gmp-news/gmp-aktuell/fda-cell-based-viral-vaccines.html FDA issued the final guidance to help manufacturers who are developing safe and effective cell-based viral vaccines to address emerging and pandemic threats. The guidance was published on March 2, 2010 by the FDA (U.S. Food and Drug Administration.

Titled “Guidance for Industry: Characterization and Qualification of Cell Substrates and Other Biological Materials Used in the Production of Viral Vaccines for Infectious Disease Indications,” the document will aid manufacturers who wish to use new cell substrates for vaccine production, such as for influenza vaccines. Currently, all licensed influenza vaccines are produced in chicken eggs.

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Tue, 09 Mar 2010 23:00:00 +0000
<![CDATA[Sterilization: Guidance for Industry (FDA)]]> http://gmpupdate.swhosting6.de/en/gmp-news/gmp-aktuell/sterilization-guidance-for-industry-fda.html On February 25, 2010 FDA published a Guidance for Industry "Submission of Documentation in Applications for Parametric Release of Human and Veterinary Drug Products Terminally Sterilized by Moist Heat Processes".

This guidance provides recommendations to applicants on information to include in support of parametric release for sterile products terminally sterilized by moist heat when submitting a new drug application (NDA), abbreviated new drug application (ANDA), new animal drug application (NADA), abbreviated new animal drug application (ANADA), biologics license application (BLA), or supplement or other postmarketing report.

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Mon, 08 Mar 2010 23:00:00 +0000
<![CDATA[CAPA: Important and Necessary for Devices]]> http://gmpupdate.swhosting6.de/en/gmp-news/gmp-aktuell/capa-important-and-necessary-for-devices.html On Feburary 5, 2010 the FDA published a Warning Letter, adressed to a manufacturer of medical devices (automated external defibrillator devices). The staff failed to identify and initiate CAPA-measures.

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Sun, 07 Mar 2010 23:00:00 +0000
<![CDATA[EMA: Linguisitic Review]]> http://gmpupdate.swhosting6.de/en/gmp-news/gmp-aktuell/ema-linguisitic-review.html A linguistic review of product information in all EU languages is performed. This should ensure high quality and consistent product information of Centrally Authorised Products in all Member States.

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Tue, 02 Mar 2010 23:00:00 +0000
<![CDATA[Orphan Drug Designatignation Annual Report]]> http://gmpupdate.swhosting6.de/en/gmp-news/gmp-aktuell/orphan-drug-designatignation-annual-report.html On February 26, 2010 EMA announced, that in recognition of World Rare Disease Day (the last day of February), the FDA and the EMA have agreed to accept the submission of a single annual report from sponsors of orphan products (drugs and biologics) designated for both the US and the EU.

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Tue, 02 Mar 2010 23:00:00 +0000
<![CDATA[Herbal Medicinal Products]]> http://gmpupdate.swhosting6.de/en/gmp-news/gmp-aktuell/herbal-medicinal-products.html The EUs Comittee on Herbal Medicinal Products (HMPC) has established the ‘Community list of herbal substances , preparations and combinations thereof for use in traditional herbal medicinal products’. The list is being gradually developed through entries of structured information relating to individual herbal substances or preparations.

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Mon, 01 Mar 2010 23:00:00 +0000
<![CDATA[Radiation Criteria - Public Consultation]]> http://gmpupdate.swhosting6.de/en/gmp-news/gmp-aktuell/radiation-criteria-public-consultation.html The European Commissions 1997 publication on Radiation Protection, concerning Radiation Criteria for Acceptability of Medical Radiological Equipment Used in Diagnostic Radiology, Nuclear Medicine and Radiotherapy, is going to be updated this year. According to the Council Directive 97/43/EURATOM the EU Member States' competent authorities shall adopt specific criteria of acceptability for equipment in order to indicate when appropriate remedial action is necessary. This includes, if appropriate, taking the equipment out of service.

 

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Sun, 28 Feb 2010 23:00:00 +0000
<![CDATA[CEP-Certificates: Update on Application Forms]]> http://gmpupdate.swhosting6.de/en/gmp-news/gmp-aktuell/cep-certificates-update-on-application-forms.html Updated CEP (Certificate of Suitability) application forms for new applications and revisions/renewals were published on February 9, 2010, by the EDQM (European Directorate for the Quality of Medicines & HealthCare).

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Wed, 24 Feb 2010 23:00:00 +0000
<![CDATA[Bayesian Statistical Methods]]> http://gmpupdate.swhosting6.de/en/gmp-news/gmp-aktuell/bayesian-statistical-methods.html On Feburary 5, 2010 FDA published a guidance on Bayesian statistical methods in the design and analysis of medical device clinical trials. The results could be less costs and more efficient patient studies.

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Mon, 22 Feb 2010 23:00:00 +0000
<![CDATA[Focus on GMP Training]]> http://gmpupdate.swhosting6.de/en/gmp-news/gmp-aktuell/focus-on-gmp-training.html On January 14, 2010 FDA published a Warning Letter, concerning amongst others a lack of cGMP violations in training affairs.  As you can see there, training-affairs are an important GMP aspect and there will be serious consequences when ignoring them.

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Thu, 18 Feb 2010 23:00:00 +0000
<![CDATA[Learn from FDA Warning Letters]]> http://gmpupdate.swhosting6.de/en/gmp-news/gmp-aktuell/learn-from-fda-warning-letters.html When FDA finds that a manufacturer has significantly violated FDA regulations, FDA notifies the manufacturer. This notification is often in the form of a Warning Letter.

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Wed, 17 Feb 2010 23:00:00 +0000
<![CDATA[Inhaler Classification System]]> http://gmpupdate.swhosting6.de/en/gmp-news/gmp-aktuell/inhaler-classification-system.html On Feburary 17, 2010 the german APV (Arbeitsgemeinschaft für Pharmazeutische Verfahrenstechnik e.V.) published an interesting Classification of  Inhaler Systems, contributed by  Carsten Kremer PhD.

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Wed, 17 Feb 2010 23:00:00 +0000
<![CDATA[USP 33-NF 28 Recall]]> http://gmpupdate.swhosting6.de/en/gmp-news/gmp-aktuell/usp-33-nf-28-recall.html USP has recalled USP 33–NF 28 because of text errors that were introduced during conversion to a new format. The USP intends to reissue the publication in March 2010. Further information about the recall is available in two public notices released on January 8, 2010 and January 12, 2010.

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Tue, 16 Feb 2010 23:00:00 +0000
<![CDATA[Lack of Hygiene]]> http://gmpupdate.swhosting6.de/en/gmp-news/gmp-aktuell/lack-of-hygiene.html On Feburary 16, 2010 the FDA published a Warning Letter concerning cGMP-Violations caused by lack of Hygiene during the manufacturing process and inaccurate personal hygiene.

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Tue, 16 Feb 2010 23:00:00 +0000
<![CDATA[Vet Quality: Public Consultation]]> http://gmpupdate.swhosting6.de/en/gmp-news/gmp-aktuell/vet-quality-public-consultation.html The Committee for Medicinal Products for Veterinary Use (CVMP) adopted a “Concept paper on the need for revision of the guideline on stability testing for applications for variations to a marketing authorisation” (EMA/63033/2010-CONSULTATION) for a 2-month period of public consultation. Revision is required because of recent changes to the underlying variations legislation.

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Sun, 14 Feb 2010 23:00:00 +0000
<![CDATA[EMA: Roadmap to 2015]]> http://gmpupdate.swhosting6.de/en/gmp-news/gmp-aktuell/ema-roadmap-to-2015.html The European Medicines Agency has launched a three-month public consultation on its Road Map to 2015, coinciding with its 15th anniversary on 26 January 2010.

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Wed, 10 Feb 2010 23:00:00 +0000
<![CDATA[FDA Guidance: Medically Necessary Drugs]]> http://gmpupdate.swhosting6.de/en/gmp-news/gmp-aktuell/fda-guidance-medically-necessary-drugs.html On January 14, 2010, the US Food and Drug Administration published a guidance that is intended to ensure the availability of medically necessary drug products (MNPs) during emergencies such as an influenza pandemic. The guidance cites the Center for Drug Evaluation and Research’s (CDER’s) definition of a medically necessary drug product as any drug used to treat or prevent a serious disease for which no appropriate substitute is adequately available.

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Tue, 09 Feb 2010 23:00:00 +0000
<![CDATA[ICH Q8,9,10 Workshops]]> http://gmpupdate.swhosting6.de/en/gmp-news/gmp-aktuell/ich-q8910-workshops.html ICH's "Quality Implementation Working Group" offers in 2010 several Integrated Implementation Training Workshops for ICH Q8, Q9 and Q10.

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Mon, 08 Feb 2010 23:00:00 +0000
<![CDATA[Annex 6 EU GMP Guideline published]]> http://gmpupdate.swhosting6.de/en/gmp-news/gmp-aktuell/annex-6-eu-gmp-guideline-published.html On Febraury 3, 2010 the European Commission published the revised Annex 6 "Manufacture of Medicinal Gases"  of the EU GMP Guideline. The Annex' deadline for comming into operation is Juliy 31, 2010.  

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Tue, 02 Feb 2010 23:00:00 +0000
<![CDATA[Annex 13 EU GMP Guideline published]]> http://gmpupdate.swhosting6.de/en/gmp-news/gmp-aktuell/annex-13-eu-gmp-guideline-published.html On February 3, 2010 the European Commission published the revised Annex 6 "Investigational Medicinal Products" of the EU GMP Guideline. Deadline for comming into operation is until July 31, 2010.

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Tue, 02 Feb 2010 23:00:00 +0000
<![CDATA[EMA FAQ on GMP Topics]]> http://gmpupdate.swhosting6.de/en/gmp-news/gmp-aktuell/ema-faq-on-gmp-topics.html While EMA (EMEA) welcomes questions on its activities and the regulatory framework within which it operates, specific questions on the interpretation of GMP requirements should be addressed, ideally by the Qualified Person, directly to the relevant supervisory authority of the Member State in which the manufacturing authorisation holder is located. Manufacturers based in third countries should make contact through the Qualified Person of the authorised importer.

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Mon, 01 Feb 2010 23:00:00 +0000
<![CDATA[Definition "Grade A air supply"]]> http://gmpupdate.swhosting6.de/en/gmp-news/gmp-aktuell/definition-grade-a-air-supply.html The new revision of Annex 1 mentions a new term, Grade A air supply, but no definition of this new term is given in the revised Annex. Inspectors and Industry therefore need an interpretation of this term, especially as a provision of a grade A air supply is one of the most significant changes in Annex 1.

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Sun, 31 Jan 2010 23:00:00 +0000
<![CDATA[PIC/S: Re-Interpretation of Annex 1]]> http://gmpupdate.swhosting6.de/en/gmp-news/gmp-aktuell/pic-s-re-interpretation-of-annex-1.html PIC/S has published a revised version of the recently adopted Recommendation for the technical interpretation of Annex 1 to the PIC/S GMP Guide, which has been prepared by Switzerland / Swissmedic. The Recommendation entered into force on 1 January 2010.

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Wed, 27 Jan 2010 23:00:00 +0000
<![CDATA["FDA Basics" web ressource launched]]> http://gmpupdate.swhosting6.de/en/gmp-news/gmp-aktuell/fda-basics-web-ressource-launched.html On January 12, 2010, as the first phase of the agency's Transparency Initiative, FDA launched a web-based resource called FDA Basics that provides basic information about the agency and how it does its work.

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Mon, 25 Jan 2010 23:00:00 +0000
<![CDATA[Example of QRM Implementation]]> http://gmpupdate.swhosting6.de/en/gmp-news/gmp-aktuell/example-of-qrm-implementation.html An informal Working Group within PIC/S has developed an example of methodology for the implementation of Quality Risk Management (QRM) in the pharmaceutical industry.

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Sun, 24 Jan 2010 23:00:00 +0000
<![CDATA[2010 Work Plan for the EMA GMP/ GDP IWG]]> http://gmpupdate.swhosting6.de/en/gmp-news/gmp-aktuell/2010-work-plan-for-the-ema-gmp-gdp-iwg.html EMA (EMEA) has published their 2010 Work Plan for the GMP/ GDP Inspectors Working Group on January 12, 2010. Among other themes, there are several GMP and GDP topics concerning the EU GMP Guide identified as "high priority"  in 2010. Topics with "low priority" and all further informations concerning the Work Plan for 2010 you find in the document linked below.

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Tue, 19 Jan 2010 23:00:00 +0000
<![CDATA[Part III of the EU GMP Guide planed]]> http://gmpupdate.swhosting6.de/en/gmp-news/gmp-aktuell/part-iii-of-the-eu-gmp-guide-planed.html The European Commission's Draft Group Enterprise and Industry launches a public consultation on Part III of the good manufacturing practices laying down guidance to manufacturers in preparing site master files. The European Commission published this draft document on January 12, 2010. The consultation period ends on March 31, 2010.

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Mon, 18 Jan 2010 23:00:00 +0000
<![CDATA[EMA: Dedicated Facilities for Critical Products]]> http://gmpupdate.swhosting6.de/en/gmp-news/gmp-aktuell/ema-dedicated-facilities-for-critical-products.html EMA (former EMEA) is currently updating chapters 3 and 5 of the EU GMP Guide concerning self-contained facilities for critical products. In some circumstances it is necessary to manufacture certain products in dedicated and self-contained facilities where the risks to patients posed by accidental cross contamination of other products is high.

Despite the the documents are still in revision, there are already some points to consider:

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Sun, 17 Jan 2010 23:00:00 +0000
<![CDATA[Changes of EU GMP Guide due to ICH Q10]]> http://gmpupdate.swhosting6.de/en/gmp-news/gmp-aktuell/changes-of-eu-gmp-guide-due-to-ich-q10.html Due to a revision of Chapters 1 and 2 of the EU GMP Guide in 2010 there should be an alignment with the concepts described in ICH Q10.

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Tue, 12 Jan 2010 23:00:00 +0000
<![CDATA[European Medicines Agency: New contact information]]> http://gmpupdate.swhosting6.de/en/gmp-news/gmp-aktuell/european-medicines-agency-new-contact-information.html From 8 December 2009 onwards, the 'emea' part of the European Medicines Agency's website and e-mail addresses is replaced with 'ema'.

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Wed, 06 Jan 2010 23:00:00 +0000
<![CDATA[Seasonal Greetings]]> http://gmpupdate.swhosting6.de/en/gmp-news/gmp-aktuell/seasonal-greetings.html The Maas & Peither team would like to thank you for your continuous patronage. At this point we would like to especially thank the numerous partners and authors which are supporting us to keep our products up to the highest standards - so that our clients have the latest information at hand. We could not do this without you!

Season's Greetings and a prosperous New Year

Your Maas & Peither Team

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Tue, 22 Dec 2009 23:00:00 +0000
<![CDATA[FDA: New ICH Q4B Annexes 5, 8, 11 &12]]> http://gmpupdate.swhosting6.de/en/gmp-news/gmp-aktuell/fda-new-ich-q4b-annexes-5-8-11-12.html FDA published recently the new ICH Q4B Annexes as Guidance for Industry.

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Mon, 21 Dec 2009 23:00:00 +0000
<![CDATA[FDA Opens New Office in Mexico]]> http://gmpupdate.swhosting6.de/en/gmp-news/gmp-aktuell/fda-opens-new-office-in-mexico.html FDA Expands Presence Outside U.S. with Opening of Mexico City Post the third in Latin America and the tenth internationally.

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Thu, 17 Dec 2009 23:00:00 +0000
<![CDATA[NEW cGMP Guidance on PET Drugs]]> http://gmpupdate.swhosting6.de/en/gmp-news/gmp-aktuell/new-cgmp-guidance-on-pet-drugs.html FDA published December 9 the new Guidance for positron emission tomography (PET) drugs.

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Wed, 16 Dec 2009 23:00:00 +0000
<![CDATA[New LOGFILE]]> http://gmpupdate.swhosting6.de/en/gmp-news/gmp-aktuell/new-logfile.html Contract manufacturing is the hot topic of the December newsletter from Maas & Peither for GMP experts in the pharmaceutical industry.

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Wed, 09 Dec 2009 23:00:00 +0000
<![CDATA[API Warning Letter]]> http://gmpupdate.swhosting6.de/en/gmp-news/gmp-aktuell/api-warning-letter.html A warning letter for a French API manufacturer was issued for cGMP deficiencies. There has been four major observations which forced the warning letter.

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Sun, 29 Nov 2009 23:00:00 +0000
<![CDATA[GMP MANUAL Update No. 08]]> http://gmpupdate.swhosting6.de/en/gmp-news-updates/gmp-aktuell/gmp-manual-update-no-08.html What is new?

The eighth update of the GMP MANUAL encompasses approx. 650 pages for the
printed version. We have outlined the contents of Update 08 below:

“GMP in Practice”

Updated Chapters:

  • Chapter 3 Premises:
    3.A: Official Requirements
    3.C: Room Classes
    3.F: Building Services
  • Chapter 8: Cleaning Validation (entire chapter)
  • Chapter 9: Computer Validation:
    9.B Regulatory Aspects
    9.D Risk Analysis and System Classification
  • Chapter 11: Production
    11.E.3.2 US Requirements

New Chapters:

  • Chapter 3 Premises:
    3.E: Barrier Systems and Isolators
    3.H: Process Gases
    3.I: Qualification of Premises and Air-Conditioning Systems
    3.J: Monitoring of HVAC Systems
    3.K: References
  • Chapter 8: Cleaning Validation:
    8.K References
  • Chapter 9: Computer Validation:
    9.H References
  • Chapter 14: Laboratory and analytical controls:
    14.L Pharmacopoeias
    14.M References

“GMP Regulations”

Updated Chapters:

  • Chapter A: Information
    A.3: Abbreviations
  • Chapter D: USA: CFR and FDA Guidelines
    D.13: 21 CFR Part 820
    D.16: Federal Food, Drug, and Cosmetic Act (link to revised version)
  • Chapter E: ICH-Guidelines
    E.4.B: ICH Q4B Annex 2 and Annex 3 (now Step 4)

New Chapters:

  • Chapter D: USA: CFR and FDA Guidelines
    D.15: Guidance for Industry: CGMP for Phase 1 Investigational Drugs
  • Chapter E: ICH-Guidelines
    E.4.B: ICH Q4B: Annex 4–10
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Wed, 25 Nov 2009 23:00:00 +0000
<![CDATA[The "Problem" is Variability]]> http://gmpupdate.swhosting6.de/en/gmp-news/gmp-aktuell/the-problem-is-variability.html QbD, PAT, Design Space - Evdokia Korakianiti, EMEA Quality Sector, gave a lecture about this issue recently in London.

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Tue, 24 Nov 2009 23:00:00 +0000
<![CDATA[Revision for Radiopharmaceuticals]]> http://gmpupdate.swhosting6.de/en/gmp-news/gmp-aktuell/revision-for-radiopharmaceuticals.html EU revises the guideline on radiopharmaceuticals based on Monoclonal Antibodies.

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Sun, 22 Nov 2009 23:00:00 +0000
<![CDATA[Outsourcing GMP Activities]]> http://gmpupdate.swhosting6.de/en/gmp-news/gmp-aktuell/outsourcing-gmp-activities.html EU revises regulation on outsourcing GMP activities. The GMP/GDP Inspectors Working Group proposes a revision of Chapter 7 "Contract Manufacture and Analysis" of the EU GMP Guide in order to upgrade guidance of outsourced GMP activities.

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Thu, 19 Nov 2009 23:00:00 +0000
<![CDATA[Combination Products 21 CFR 4]]> http://gmpupdate.swhosting6.de/en/gmp-news/gmp-aktuell/combination-products-21-cfr-4.html FDA extended the comment period for the proposed rule on Good Manufacturing Practices (GMPs) on combination products until February 5, 2010. This regulation will be interesting for every pharmaceutical company that delivers combination products.

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Wed, 18 Nov 2009 23:00:00 +0000
<![CDATA[EMEA and FDA work close together]]> http://gmpupdate.swhosting6.de/en/gmp-news/gmp-aktuell/emea-and-fda-work-close-together.html Get an insight on the progress of collaboration between EMEA and FDA. The European Commission published recently the Implementation report 2009 on the "Transatlantic Administrative Simplification Action Plan".

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Wed, 11 Nov 2009 23:00:00 +0000
<![CDATA[Drug Dosis Delivery for OTC Liquied Drug Products]]> http://gmpupdate.swhosting6.de/en/gmp-news/gmp-aktuell/drug-dosis-delivery-for-otc-liquied-drug-products.html The Food and Drug Administration (FDA) made public a new guidance for companies that manufacture, market, or distribute over-the-counter liquid medications packaged with dosage delivery devices such as calibrated cups, droppers, syringes and spoons. The guidance document, titled “Dosage Delivery Devices for OTC Liquid Drug Products,” was posted for advanced viewing in the Federal Register on November 4, 2009.

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Wed, 04 Nov 2009 23:00:00 +0000
<![CDATA[Quality by Design - Regulators Opinion]]> http://gmpupdate.swhosting6.de/en/gmp-news/gmp-aktuell/quality-by-design-regulators-opinion.html Quality by Design (QbD) is a tool that is promoted through the recent ICH series Q8/Q9/Q10. We visited the most recent conferences and noticed a high interest in this topic. Now EMEA published a presentation of David Cockburn, held at the EMEA/Efpia QbD Application Workshop in London (Sept 29, 2009).

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Sun, 25 Oct 2009 23:00:00 +0000
<![CDATA[USP Heparin Monograpf Q&A]]> http://gmpupdate.swhosting6.de/en/gmp-news/gmp-aktuell/usp-heparin-monograpf-q-a.html The U.S. Food and Drug Administration (FDA) has alerted healthcare professionals to changes in the United States Pharmacopeia (USP) monograph for heparin products, effective October 1, 2009. Heparin made using the tests and reference standards in the new USP monograph will become available in healthcare facilities on or after October 8, 2009.

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Tue, 20 Oct 2009 22:00:00 +0000
<![CDATA[EMEA Announced New Guidelines]]> http://gmpupdate.swhosting6.de/en/gmp-news/gmp-aktuell/emea-announced-new-guidelines.html David Cockburn, EMEA, announced last week at the PDA/EMEA Joint Conference in Berlin, that EMEA will work on changes of the EU-GMP-Guide (chapters & annexes).

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Mon, 19 Oct 2009 22:00:00 +0000
<![CDATA[Maas & Peither at PDA/EMEA Conference]]> http://gmpupdate.swhosting6.de/en/gmp-news/gmp-aktuell/maas-peither-at-pda-emea-conference.html Today the PDA/EMEA Joint Conference starts in Berlin, Germany. Maas & Peither is present at booth #18 at this important European Conference.

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Mon, 12 Oct 2009 22:00:00 +0000
<![CDATA[EMEA implement PIM]]> http://gmpupdate.swhosting6.de/en/gmp-news/gmp-aktuell/emea-implement-pim.html The EMEA intends to fully implement its Product Information Management (PIM) approach, an initiative designed to improve information management, into the centralized procedure within 2 years, according to a statement of intent from the agency.

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Sun, 11 Oct 2009 22:00:00 +0000
<![CDATA[FDAs Risk Communication]]> http://gmpupdate.swhosting6.de/en/gmp-news/gmp-aktuell/fdas-risk-communication.html The FDA is enforcing their effort to make knowledge public and transparent. The recent initiative is handling the risk communication to consumers and stakeholders.

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Sun, 04 Oct 2009 22:00:00 +0000
<![CDATA[NEW FDA Risk Guidance]]> http://gmpupdate.swhosting6.de/en/gmp-news/gmp-aktuell/new-fda-risk-guidance.html FDA Issues Draft Guidance on Risk Evaluation and Mitigation Strategies (REMS)

The U.S. Food and Drug Administration today announced the availability of the first draft guidance for industry on Risk Evaluation and Mitigation Strategies or REMS, which are required for certain drugs or biologics in the submission process.

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Thu, 01 Oct 2009 22:00:00 +0000
<![CDATA[Recent Published CGMP Warning Letter]]> http://gmpupdate.swhosting6.de/en/gmp-news/gmp-aktuell/recent-published-cgmp-warning-letter.html The FDA published Tuesday a Warning Letter that was sent to Ion Labs, Inc., on July 31, 2009. The reasons were not adequate procedures, SOPs, records, approvals, calibration, specifications, test programs.

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Wed, 30 Sep 2009 22:00:00 +0000
<![CDATA[FDA´s Sharfstein Outlines Principles]]> http://gmpupdate.swhosting6.de/en/gmp-news/gmp-aktuell/fda´s-sharfstein-outlines-principles.html US Food and Drug Administration Principal Deputy Commissioner Joshua Sharfstein outlined four principles that define FDA’s role as a public health agency at the PDA/FDA Regulatory Joint Conference in Washington September 14, 2009. Mr. Sharfstein opened the conference with his presentation.

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Tue, 29 Sep 2009 22:00:00 +0000
<![CDATA[GMP MANUAL Update No. 07]]> http://gmpupdate.swhosting6.de/en/gmp-news-updates/gmp-aktuell/gmp-manual-update-no-07.html What is new?

The seventh Update of the GMP MANUAL encompasses approx. 500 pages for the printed version and additionally 400 pages for the CD/online version. For a brief overview of the contents see below:

“GMP in Practice”

Updated Chapters:

  • Chapter 11:   Production

New Chapters:

  • Chapter 19:   Quality Unit (Qualified Person)
  • Chapter 20:   Continual Improvement Methods (Six Sigma)
“GMP Regulations”

Updated chapters

  • Chapter C.1          EU-GMP Guide: Introduction
  • Chapter C.6.3       EU-GMP Guide:Annex 3 Manufacture of Radiopharmaceuticals
  • Chapter C.6.7       EU-GMP Guide:Annex 7 Manufacture of Herbal Medicinal Products
  • Chapter E.8          ICH Q8 (R1) Pharmaceutical Development
  • Chapter F      PIC/S PI 007 Recommendation on the Validation of Aseptic Processes

New chapters

  • Chapter C.10        EU-GMP Guide Compilation of Community Procedures
  • Chapter E.1.D       ICH Q1D Bracketing and Matrixing Designs for Stability Testing of new Drug Substances and Products
  • Chapter E.1.E        ICH Q1E Evaluation for Stability Data
  • Chapter G.1           WHO Quality Assurance of Pharmaceuticals (only on CD/online)
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Thu, 24 Sep 2009 22:00:00 +0000
<![CDATA[New MANUFACTURING book]]> http://gmpupdate.swhosting6.de/en/gmp-news/gmp-aktuell/new-manufacturing-book.html The new GMP publication "MANUFACTURING" was announced by Maas & Peither at  the PDA/FDA Joint Regulatory Conference in Washington . The book is an compilation of four chapters from the GMP MANUAL that are related to the manufacturing area.

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Wed, 23 Sep 2009 22:00:00 +0000
<![CDATA[ICH Japan Symposium 2009]]> http://gmpupdate.swhosting6.de/en/gmp-news/gmp-aktuell/ich-japan-symposium-2009.html ICH recently published the proceedings of the ICH public Meeting held on June 12, 2009 in Tokyo on it´s website.

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Tue, 22 Sep 2009 22:00:00 +0000
<![CDATA[FDA doubles foreign inspections]]> http://gmpupdate.swhosting6.de/en/gmp-news/gmp-aktuell/fda-doubles-foreign-inspections.html The number of foreign inspections in foreign countries will rise dramatically in 2009 .

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Wed, 16 Sep 2009 22:00:00 +0000
<![CDATA[FDA Updates Warning Letter Web page]]> http://gmpupdate.swhosting6.de/en/gmp-news/gmp-aktuell/fda-updates-warning-letter-web-page.html The U.S. Food and Drug Administration has reorganized and updated the warning letters page in the Inspections, Compliance, Enforcement, and Criminal Investigations section of the FDA Web site.

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Tue, 15 Sep 2009 22:00:00 +0000
<![CDATA[Logfile No. 5 - Quality Management System]]> http://gmpupdate.swhosting6.de/en/gmp-news/gmp-aktuell/logfile-no-5-quality-management-system.html The latest Maas & Peither newsletter "LOGFILE" has just been sent to our valued customers and subscribers.  It delivers current GMP information, comments on upcoming trends and informs you about industry & regulatory news.

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Thu, 10 Sep 2009 22:00:00 +0000
<![CDATA[PIC/S revised GMP Guide]]> http://gmpupdate.swhosting6.de/en/gmp-news/gmp-aktuell/pic-s-revised-gmp-guide.html PIC/S adopted the revisions of the GMP Guide PE 009-9 at the last meeting in Geneva on May 5-6. They come into force on September 1, 2009 and March 1, 2010 (capping of vials).

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Tue, 08 Sep 2009 22:00:00 +0000
<![CDATA[Quality by Design (QbD)]]> http://gmpupdate.swhosting6.de/en/gmp-news/gmp-aktuell/quality-by-design-qbd.html the International Pharmaceutical Excipients Council published recently a Questions & Answers document on Quality by Design (QbD). The paper gives a good overview about questions that could help the meet the goals in the pharmaceutical industry.

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Sun, 06 Sep 2009 22:00:00 +0000
<![CDATA[GMP - Inspection of Global Supply Chain]]> http://gmpupdate.swhosting6.de/en/gmp-news/gmp-aktuell/gmp-inspection-of-global-supply-chain.html EFPIA (European Federation of Pharmaceutical Industries and Associations) published recently a interesting position paper about " GMP - Inspection of Global Pharmaceutical Supply Chains".

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Thu, 03 Sep 2009 22:00:00 +0000
<![CDATA[New PDA President appointed]]> http://gmpupdate.swhosting6.de/en/gmp-news/gmp-aktuell/new-pda-president-appointed.html The PDA has announced the appointment of Richard M. Johnson as the Association’s next President, effective September 2009.

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Wed, 02 Sep 2009 22:00:00 +0000
<![CDATA[EMEA/EFPIA QbD Workshop]]> http://gmpupdate.swhosting6.de/en/gmp-news/gmp-aktuell/emea-efpia-qbd-workshop.html EMEA announced that EFPIA and EMEA have organized a workshop to bring together industry representatives together with European assessors and inspectors at a workshop that take place in London September 29, 2009.

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Mon, 31 Aug 2009 22:00:00 +0000
<![CDATA[Review of Post-Inspection Responses (form 483)]]> http://gmpupdate.swhosting6.de/en/gmp-news/gmp-aktuell/review-of-post-inspection-responses-form-483.html FDA published in Federal Register / Vol. 74, No. 153 / Tuesday, August 11, 2009, to start a new program concerning the handling of form FDA 483. The program will start September 15, 2009 and will run 18 months.

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Sun, 30 Aug 2009 22:00:00 +0000
<![CDATA[FDA Proposes Mandatory Electronic Safety Reporting]]> http://gmpupdate.swhosting6.de/en/gmp-news/gmp-aktuell/fda-proposes-mandatory-electronic-safety-reporting.html New Rules will help strengthen postmarket safety data collection

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Tue, 25 Aug 2009 22:00:00 +0000
<![CDATA[Regulatory Roundup: FDA Reorganizes the Office of the Commissioner, more....]]> http://gmpupdate.swhosting6.de/en/gmp-news/gmp-aktuell/regulatory-roundup-fda-reorganizes-the-office-of-the-commissioner-more.html The US Food and Drug Administration is reorganizing the Office of the Commissioner (OC), according to an Aug. 18 Federal Register announcement. Being realigned are four Deputy-level offices: the Office of the Chief Scientist; the Office of Administration (formerly titled the Office of Operations); the Office of Foods; and the Office of Policy, Planning and Budget (formerly titled the Office of Policy, Planning and Preparedness).

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Thu, 20 Aug 2009 22:00:00 +0000
<![CDATA[FDA: Warning Letter Enforcement Begins in September]]> http://gmpupdate.swhosting6.de/en/gmp-news/gmp-aktuell/fda-warning-letter-enforcement-begins-in-september.html The US Food and Drug Administration announced a new program regarding the issuance of warning letters to the pharmaceutical industry. Published in the Aug. 11 Federal Register, the program is meant to better support public health protection by establishing a timeframe for “the submission and agency review of post-inspection responses to inspectional observations” that are sent to a company via a FDA 483 form, according to the Register.

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Thu, 20 Aug 2009 22:00:00 +0000
<![CDATA[USA: Federal Guidelines encourage employers to plan now for upcoming Influenza Season]]> http://gmpupdate.swhosting6.de/en/gmp-news/gmp-aktuell/usa-federal-guidelines-encourage-employers-to-plan-now-for-upcoming-influenza-season.html Department of Commerce (DOC) Secretary Gary Locke, Department of Health and Human Services (HHS) Secretary Kathleen Sebelius, and Homeland Security (DHS) Secretary Janet Napolitano today announced new guidance for businesses to plan for and respond to the upcoming flu season.

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Wed, 19 Aug 2009 22:00:00 +0000
<![CDATA[PDA/EMEA Joint Conference ]]> http://gmpupdate.swhosting6.de/en/gmp-news/gmp-aktuell/pda-emea-joint-conference-.html "Ensuring Patient Safety through Supply Chain Control and GMP"
13-14 October 2009 / Berlin, Germany
Meet the Maas & Peither Team in person at this important event.

 

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Mon, 17 Aug 2009 22:00:00 +0000
<![CDATA[Companies update activities for pandemic and seasonal flu vaccines]]> http://gmpupdate.swhosting6.de/en/gmp-news/gmp-aktuell/companies-update-activities-for-pandemic-and-seasonal-flu-vaccines.html Baxter International (Deerfield, IL), sanofi aventis (Paris), and Novartis (Basel, Switzerland) provided updates last week of their production and regulatory activities relating to preparedness in supplying the A(H1N1) pandemic influenza vaccine. Novartis also outlined its activities for providing seasonal flu vaccines.

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Thu, 13 Aug 2009 22:00:00 +0000
<![CDATA[FDA Commissioner sets out vision on enforcement to support public health]]> http://gmpupdate.swhosting6.de/en/gmp-news/gmp-aktuell/fda-commissioner-sets-out-vision-on-enforcement-to-support-public-health.html Commissioner of Food and Drugs Margaret A. Hamburg, M.D., today outlined her commitment “to prevent harm to the American people” through swift, aggressive, and effective enforcement of FDA laws and regulations.

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Wed, 12 Aug 2009 22:00:00 +0000
<![CDATA[2009 PDA/FDA Joint Regulatory Conference ]]> http://gmpupdate.swhosting6.de/en/gmp-news/gmp-aktuell/2009-pda-fda-joint-regulatory-conference-.html Come and meet Thomas Peither, President of Maas & Peither America, Inc. in person at the 2009 PDA/FDA Joint Regulatory Conference in Washington, D.C. (September 2009).  

 

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Mon, 10 Aug 2009 22:00:00 +0000
<![CDATA[EMEA: Announcement of European Medicines Agency priorities for adverse drug reaction research]]> http://gmpupdate.swhosting6.de/en/gmp-news/gmp-aktuell/emea-announcement-of-european-medicines-agency-priorities-for-adverse-drug-reaction-research.html  At its plenary meeting on 19 March 2009, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) adopted its 2010 priorities for drug safety research based on recommendations from the CHMP’s Pharmacovigilance Working Party.

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Sun, 09 Aug 2009 22:00:00 +0000
<![CDATA[NEW FDA Guidance for Industry: Pharmaceutical Components at Risk for Melamine Contamination]]> http://gmpupdate.swhosting6.de/en/gmp-news/gmp-aktuell/new-fda-guidance-for-industry-pharmaceutical-components-at-risk-for-melamine-contamination.html FDA Center for Drug Evaluation and Research (CDER) and Center for Veterinary Medicine (CVM) published today a new Guidance for Industry: "Pharmaceutical Components at Risk for Melamine Contamination"

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Thu, 06 Aug 2009 22:00:00 +0000
<![CDATA[GMP MANUAL Update 07 is coming in September]]> http://gmpupdate.swhosting6.de/en/gmp-news/gmp-aktuell/gmp-manual-update-07-is-coming-in-september.html The next update of the GMP MANUAL the most powerful cGMP knowledge base is announced for late September 2009. Read about the content on our UPDATE WEBPAGE

Link to GMP MANUAL Update No. 07

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Wed, 05 Aug 2009 22:00:00 +0000
<![CDATA[EudraGMP 2.0 gives public access to database]]> http://gmpupdate.swhosting6.de/en/gmp-news/gmp-aktuell/eudragmp-20-gives-public-access-to-database.html Following the launch of a new version the EudraGMP database is now providing public access to information about manufacturing, importation authorisations and Good Manufacturing Practice (GMP) certificates.

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Tue, 04 Aug 2009 22:00:00 +0000
<![CDATA[EMEA publish Q&A on Calculation of Thresholds for Impurities]]> http://gmpupdate.swhosting6.de/en/gmp-news/gmp-aktuell/emea-publish-q-a-on-calculation-of-thresholds-for-impurities.html Question: What is the basis for the calculation of thresholds to set limits for impurities in the finished product specification?

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Mon, 03 Aug 2009 22:00:00 +0000
<![CDATA[FDA & EMEA Launch Good Clinical Practice Initiative]]> http://gmpupdate.swhosting6.de/en/gmp-news/gmp-aktuell/fda-emea-launch-good-clinical-practice-initiative.html Collaborative effort aims to ensure appropriate conduct of clinical trials. Initiative pilot phase starts on 1st of September 2009. Is this a starting point for further initiatives between FDA and EMEA also in the GMP area?

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Mon, 03 Aug 2009 22:00:00 +0000
<![CDATA[US FDA Takes Action against Teva Animal Health because of cGMP deficiencies]]> http://gmpupdate.swhosting6.de/en/gmp-news/gmp-aktuell/us-fda-takes-action-against-teva-animal-health-because-of-cgmp-deficiencies.html Company fails to adhere to current Good Manufacturing Practice regulations.

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Sun, 02 Aug 2009 22:00:00 +0000
<![CDATA[New website of Maas & Peither goes online]]> http://gmpupdate.swhosting6.de/en/gmp-news/gmp-aktuell/new-website-of-maas-peither-goes-online.html As of today the new website of Maas & Peither GMP Publishing is online. You will now get more & better information than before. Click on "read more" to learn more about the new features.

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Thu, 30 Jul 2009 22:00:00 +0000
<![CDATA[FDA published warning letter for medical device manufacturer ]]> http://gmpupdate.swhosting6.de/en/gmp-news/gmp-aktuell/fda-published-warning-letter-for-medical-device-manufacturer-.html On July 22, 2009, FDA published a warning letter concerning cGMP deviations to the medical device manufacturer Ohio Medical Corp. The warning letter is referencing to the FDA Good Manufacturing Practices for medical device manufacturer 21 CFR 820.

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Tue, 28 Jul 2009 22:00:00 +0000
<![CDATA[ICH updated Q8/Q9/Q10 Q&A document]]> http://gmpupdate.swhosting6.de/en/gmp-news/gmp-aktuell/ich-updated-q8-q9-q10-q-a-document.html ICH Quality Implementation Working Group on Q8/Q9/Q10 updated the Questions & Answers document July 23, 2009.  Changes were made in Question #7 of the section 2.2 Real Time Release Testing: "If RTR testing results fail or trending toward failure, can end product testing be used to release the batch?"

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Tue, 28 Jul 2009 22:00:00 +0000
<![CDATA[FDA CBER published Blood Guidance for Industry]]> http://gmpupdate.swhosting6.de/en/gmp-news/gmp-aktuell/fda-cber-published-blood-guidance-for-industry.html FDA Center of Biologic Evaluation and Research (CBER) published today the new Guidance for Industry: "Nucleic Acid Testing (NAT) to Reduce the Possible Risk of Parvovirus B19 Transmission by Plasma-Derived Products"

This guidance finalizes the draft guidance of the same title, dated July 2008.

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Mon, 27 Jul 2009 22:00:00 +0000
<![CDATA[EMEA published Guideline on Data Requirements for Master Seeds]]> http://gmpupdate.swhosting6.de/en/gmp-news/gmp-aktuell/emea-published-guideline-on-data-requirements-for-master-seeds.html Guideline on Data Requirements for the Replacement of established Master Seeds (MS) already used in authorised Immunological Veterinary Medicinal Products (IVMPs) by new Master Seed of the same origin. Coming into effect February 1, 2010.

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Thu, 23 Jul 2009 22:00:00 +0000
<![CDATA[FDA Issues Draft Guidance for Industry on Drug Anticounterfeiting]]> http://gmpupdate.swhosting6.de/en/gmp-news/gmp-aktuell/fda-issues-draft-guidance-for-industry-on-drug-anticounterfeiting.html The focus is in this guideline is on physical chemical identifiers.

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Mon, 13 Jul 2009 22:00:00 +0000
<![CDATA[EMEA published Annual Report 2008]]> http://gmpupdate.swhosting6.de/en/gmp-news/gmp-aktuell/emea-published-annual-report-2008.html The European Medicines Agency has published its annual report for 2008, a highly productive year in which the Agency consolidated its work in core activity areas and made good progress with many of the initiatives it is involved in.

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Sun, 12 Jul 2009 22:00:00 +0000
<![CDATA[Change in European Community Procedures ]]> http://gmpupdate.swhosting6.de/en/gmp-news/gmp-aktuell/change-in-european-community-procedures-.html Revision to a Community procedure and a new procedure for dealing with serious GMP non-compliance are published

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Thu, 09 Jul 2009 22:00:00 +0000
<![CDATA[FDA Update on Inactive Ingredients Database]]> http://gmpupdate.swhosting6.de/en/gmp-news/gmp-aktuell/fda-update-on-inactive-ingredients-database.html Download the Inactive Ingredients file from the FDA website.

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Thu, 09 Jul 2009 22:00:00 +0000
<![CDATA[FDA CDER is on Twitter]]> http://gmpupdate.swhosting6.de/en/gmp-news/gmp-aktuell/fda-cder-is-on-twitter.html The Division of Drug Information (DDI) is CDER's focal point for public inquiries. It serves the public by providing information on human drug products and drug product regulation by FDA.

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Tue, 07 Jul 2009 22:00:00 +0000
<![CDATA[Guidance on Penecillin Drugs added to FDA website]]> http://gmpupdate.swhosting6.de/en/gmp-news/gmp-aktuell/guidance-on-penecillin-drugs-added-to-fda-website.html FDA published on June 29, 2009, a new addendum to the "Guidance for Industry: Questions & Answers on Current Good Manufacturing Practices (cGMP) for Drugs".

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Wed, 01 Jul 2009 22:00:00 +0000
<![CDATA[Canada updates GMP Guidelines in 2009]]> http://gmpupdate.swhosting6.de/en/gmp-news/gmp-aktuell/canada-updates-gmp-guidelines-in-2009.html Health Canada published its reviewed guidelines to Good Manufacturing Practice. They come into ...

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Tue, 30 Jun 2009 22:00:00 +0000
<![CDATA[Upcoming Regulations from US-FDA and Europe]]> http://gmpupdate.swhosting6.de/en/gmp-news/gmp-aktuell/upcoming-regulations-from-us-fda-and-europe.html At the Business Reception of Maas & Peither America in King of Prussia Paolomi Mukherji, Clarkston Consulting, held an interesting presentation about current GMP regulations and the latest changes of the US-FDA.

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Mon, 29 Jun 2009 22:00:00 +0000
<![CDATA[Result of Survey: "Quality Management"]]> http://gmpupdate.swhosting6.de/en/gmp-news/gmp-aktuell/result-of-survey-quality-management.html The following questions were asked:

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Mon, 29 Jun 2009 22:00:00 +0000
<![CDATA[EMEA published four Annexes to ICH Q4B]]> http://gmpupdate.swhosting6.de/en/gmp-news/gmp-aktuell/emea-published-four-annexes-to-ich-q4b.html EMEA published June 29, 2009, four annexes to the ICH Q4B "Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions".

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Sun, 28 Jun 2009 22:00:00 +0000
<![CDATA[EMEA published Q&A Document of ICH to Q8, Q9, Q10]]> http://gmpupdate.swhosting6.de/en/gmp-news/gmp-aktuell/emea-published-q-a-document-of-ich-to-q8-q9-q10.html FDA already publised this document on its website. Now EMEA also adopted this helpful document.

EMEA´s Questions & Answers to ICH Q8, Q9, Q10

mehr]]>
Sun, 28 Jun 2009 22:00:00 +0000
<![CDATA[FDA published new Guidance for Industry]]> http://gmpupdate.swhosting6.de/en/gmp-news/gmp-aktuell/fda-published-new-guidance-for-industry.html FDA published on June 26, 2009 the Guidance for Industry: Updating Labeling for Susceptibility Test Information in Systemic Antibacterial Drug Products and Antimicrobial Susceptibility Testing Devices

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Thu, 25 Jun 2009 22:00:00 +0000
<![CDATA[FDA: Transparency Task Force Public Meeting]]> http://gmpupdate.swhosting6.de/en/gmp-news/gmp-aktuell/fda-transparency-task-force-public-meeting.html For those which were interested and were unable to attend the public meeting of the Transparency Task Force - the FDA has made the meeting viewable via webcast.

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Wed, 24 Jun 2009 22:00:00 +0000
<![CDATA[RAPS is new sales partner of the GMP MANUAL]]> http://gmpupdate.swhosting6.de/en/gmp-news/gmp-aktuell/raps-is-new-sales-partner-of-the-gmp-manual.html RAPS (Regulatory Affairs Professionals Society), Rockville, MD, is the new Sales Partner of Maas & Peither America, Inc.

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Sun, 21 Jun 2009 22:00:00 +0000
<![CDATA[EMEA´s transparency policy]]> http://gmpupdate.swhosting6.de/en/gmp-news/gmp-aktuell/emea´s-transparency-policy.html European Medicines Agency launches public consultation on new transparency policy.

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Sun, 21 Jun 2009 22:00:00 +0000
<![CDATA[European Pharmacopoeia Supplement 6.6 is published]]> http://gmpupdate.swhosting6.de/en/gmp-news/gmp-aktuell/european-pharmacopoeia-supplement-66-is-published.html EDQM recently published Supplement 6.6. Get a quick overview of the contents with the table of contents.

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Sun, 07 Jun 2009 22:00:00 +0000
<![CDATA[FDA Forms Transparency Task Force]]> http://gmpupdate.swhosting6.de/en/gmp-news/gmp-aktuell/fda-forms-transparency-task-force.html The U.S. Food and Drug Administration (FDA) today announced the formation of a task force to develop recommendations for enhancing the transparency of the agency’s operations and decision-making process.

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Tue, 02 Jun 2009 22:00:00 +0000
<![CDATA[Endotoxin Testing and Sterility Testing]]> http://gmpupdate.swhosting6.de/en/gmp-news/gmp-aktuell/endotoxin-testing-and-sterility-testing.html Endotoxin Testing and Sterility Testing at the end of shelf-life. Requirements and answers to questions of the EMEA Quality Working Party, Inspections section.

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Wed, 20 May 2009 22:00:00 +0000
<![CDATA[GMP MANUAL Update No. 06]]> http://gmpupdate.swhosting6.de/en/gmp-news-updates/gmp-aktuell/gmp-manual-update-no-06.html For a brief overview of the contents (approx. 900 pages) of this sixth update please
see the following summaries:

In “GMP in Practice” we updated the following chapters:
• Chapter Contributors
• Chapter 4 Equipment
• Chapter 5 Pharmaceutical Water
• Chapter 14 Laboratory and Analytical Control

In “GMP Regulations” we updated the following chapters:
• Chapter D.1 US Regulations 21 CFR part 210 and 211
New in “GMP Regulations” is:
• Chapter E.10 ICH Q10 Pharmaceutical Quality System

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Mon, 30 Mar 2009 22:00:00 +0000
<![CDATA[GMP MANUAL Update No. 05]]> http://gmpupdate.swhosting6.de/en/gmp-news-updates/gmp-aktuell/gmp-manual-update-no-05.html For a brief view of the contents (more than 1,000 pages) of this fifth update please
see the following summaries:

In “GMP in practice” we have updated the following chapters:
• Chapter 3 Premises
• Chapter 16 Research and Development
• Chapter 18 Inspections

In “GMP regulations” we updated the following chapters:
• Chapter A, we integrated former chapter B.1-B.4 in chapter A
• Chapter C.6.20 EU-GMP-Guide Annex 20 Quality Risk Management
• Chapter E ICH Guidelines, this chapter is now reorganised
New in “GMP regulations” is:
• Chapter B with 3 Japanese Regulations
• Chapter E.5 ICH Q5 Five Regulations on Biotechnology Products
• Chapter E.8 ICH Q8 Pharmaceutical Development

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Fri, 31 Oct 2008 23:00:00 +0000
<![CDATA[GMP OPENS A NEW CHAPTER]]> http://gmpupdate.swhosting6.de/en/press/gmp-aktuell/gmp-opens-a-new-chapter.html Published by Maas & Peither - GMP Publishing

The world’s leading comprehensive reference book in the field of GMP. The GMP MANUAL provides expert up-to-date, in-depth and reliable knowledge about easy implementation of GMP as well as updated GMP regulations.

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Mon, 29 Nov 1999 23:00:00 +0000
<![CDATA[GMP MANUAL Volume 1 - Manufacturing]]> http://gmpupdate.swhosting6.de/en/press/gmp-aktuell/gmp-manual-volume-1-manufacturing.html GMP MANUAL Volume 1 – Manufacturing contains the chapters
- Production
- Packaging
- Laboratory and Analytical Control
- Documentation

Here you will find the Icon Press-release-Manufacturing.pdf

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Mon, 29 Nov 1999 23:00:00 +0000