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GMP in Practice: 24 chapters written by internationally renowned industry experts.

 

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Updates Forecast & History

2014-10-09

GMP MANUAL Update No. 19

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

 

GMP in Practice

Chapter 4 Facilities and Equipment

4.A Facility Planning

Facility planning occupies a prominent place when a facility is being designed. During this phase, all aspects of its later use must be taken into consideration and included in the facility requirements. These include, in particular, qualification procedures, materials, building and construction element requirements, hygiene requirements, cleaning capability, maintenance friendliness and special process requirements. A comprehensive and detailed implementation of this phase ensures an efficient overall project. (Thomas Peither)

4.B Materials

Different materials are required for the construction of facilities. At the same time, a distinction is made between construction materials and auxiliary materials. The author gives an overview on different types of stainless steel, their characteristics and explains their designation according to standards. Topics such as alloying, surface coating, welding techniques and corrosion are also addressed. Plastics are also often used in facility construction. Their manufacturing, classification and characteristics are discussed and the statutory requirements are explained. Sealing materials and lubricants are auxiliary materials. Here too, an overview on materials, characteristics, use and statutory requirements is given. (Ruven Brandes)

4.C Hygienic Design in Solids Handling

This chapter is still under revision and will be provided with the following update.

4.D System Controllers and Process Control Systems

In order to be able to control a process, quality-related process parameters must be measured using calibrated sensors. Checks are carried out as part of the operational qualification to ensure that parameters are kept within their limits by automatic control loops. When microprocessors or programmable logic controllers (PLCs) are used, this falls within the scope of computer validation. PLCs normally fall under Category 4 in accordance with GAMP 5 and must undergo qualification. The hardware/software functional requirements are described in the URS (user requirement specification). A thorough and efficient formulation of the URS/FS simplifies the actual qualification that follows. The scope of testing is determined by the operator during a risk analysis. The life cycle of a PLC is subject to the same requirements as the associated facility. PLC qualification can be carried out during qualification of the facility. (Rainer Röcker, Anton Steurer, Andreas Rösch)

4.E Technical Documentation

The term Technical documentation means compiling, organising and archiving technically relevant data and documents as well as providing them for information purposes. Generally, the requirements of the EU GMP Guidelines Part I, chapter 4 Documentation apply. The author discusses important contents of technical documentation and gives practical advice for managing, updating and archiving these documents, which are often very comprehensive and complex. (R. Brandes)

4.F Calibration

Process automation has become a widespread standard in modern pharmaceutical processes. As a consequence, approvals and other GMP-relevant decisions increasingly rely on the use of appropriate measurement technology, which means that the monitoring technology itself has to undergo regular function control. The author discusses statutory and normative requirements for calibration and presents the relevant contents of a calibration Master SOP. This includes identification of measuring points requiring calibration, definition of calibration intervals and selection of appropriate methods. The calibration hierarchy and the requirements for reference devices are explained. The chapter rounds up with practical advice for implementation and documentation of the calibration process. (Wolfgang Rudloff)

4.G Maintenance

Maintenance includes measures such as inspection, overhaul and repair and servicing. One of the main tasks of maintenance is to ensure the availability of machinery and facilities as needed with a minimum of product risk and maintenance costs. The author presents different maintenance strategies that should be considered when implementing a comprehensive maintenance concept: failure recovery, preventive maintenance, condition-based maintenance and predictive maintenance. Risk-based maintenance is used to make decisions about the selection of a maintenance strategy based on product and commercial risk. This type of maintenance is very effective when properly established and reduces maintenance costs. When considering the introduction of an electronic maintenance system, the cost-effectiveness of such a decision must be taken into account and the system introduced with caution. (Ruven Brandes)

4.H Cleaning of Facilities

Cleaning technology has a significant impact on the effectiveness of the cleaning process. Understanding of the process types and modes of operation is necessary when selecting effective processes and optimising them under practical conditions. The authors discuss advantages and disadvantages, capabilities and characteristics of CIP/WIP and COP processes. The design and development of cleaning processes is explained in detail. The chapter then focuses on the CIP cleaning technology. Single pass, single use and solution recovery systems are presented. Relevant aspects of GMP-compliant design and the resulting requirements for important functional elements, such as pumps, valves and nozzle heads are discussed. The chapter is completed by information on measuring technology. (Torsten Knöpke, Stefan Schneider)

4.I Containment (Personnel Protection) in Solids Handling

This chapter is still under revision and will be provided with the following update.

GMP Regulations

Chapter C: EU Directives and Guidelines

C.4 EU GMP Guide Part I – Basic Requirements for Medicinal Products

The European Commission has published the final version of the revised chapters 3, 5 and 8 of the EU GMP Guide. The deadline for implementation of all three chapters is 1 March 2015. For transparency reasons, we decided to provide you with both the current version of the chapters effective until 30 April 2015 and the revised version effective from 1 March 2015. The documents are listed successively.

C.4.3.1 Chapter 3 Premises and Equipment (effective from 1 March 2015)

In Chapter 3 Premises and Equipment only section 3.6 (Production Area) has been revised as part of the improved guidance on prevention of cross-contamination involving also Chapter 5.

C.4.5.1 Chapter 5 Production (effective from 1 March 2015)

The revised Chapter 5 Production also deals with the prevention of crosscontamination and refers to toxicological assessment (section 17–21). Changes were also introduced in sections 27-30, including a new section on the qualification of suppliers in order to reflect the legal obligation of manufacturing authorisation holders to ensure that active substances are produced in accordance with GMP. This also includes supply chain traceability. A new section 71 introduces guidance on notification of restrictions in supply.

C.4.8.1 Chapter 8 Complaints, Quality Defects and Product Recalls

This chapter was comprehensively revised. Extensive changes have been made to reflect that Quality Risk Management principles should be applied when investigating quality defects or complaints. The need to investigate and determine the cause of quality defects is emphasized. Additionally, appropriate preventative actions (e.g. root cause analysis, CAPAs) have to be put in place and quality defects should be reported to Competent Authorities.

C.5 Part II Basic Requirements for Active Substances used as Starting Materials

The European Commission has published a revised version of Part II of the EU GMP Guide. 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. The amendments canmainly be found in Section 1.2 (Scope) which now also clarifies the relationship between section 17 (Agents, Brokers, Traders, Distributors, Repackers and Relabellers) of Part II and the forthcoming guidelines on Good Distribution Practices for active substances for medicinal products for human use. The document came into operation on 1 September 2014.

C.8 EU GMP Guide Part III - GMP related documents

C.8.5.1 Importation of Active Substances for Medicinal Products for Human Use; Questions and Answers

Two new questions and their corresponding answers (Q&A 33 and 34) have been added to the new version of this document. The questions deal with GMP non-compliance statements superseding the corresponding written confirmations, if existing and the EudraGMDP database which lists all active substance manufacturing sites that received statements of GMP non-compliance.

C.18 Guidance for the template for the qualified person’s declaration concerning

GMP compliance of active substance manufacture “The QP declaration template” The EMA has published the long awaited Qualified Person (QP) declaration template and accompanying guidance concerning GMP compliance of API manufacture. The objective of this guidance and the Qualified Person (QP)declaration template is to emphasise the importance of providing a valid declaration, to harmonise the format for the declaration, to forestall questions during assessment and to enhance the efficiency of the regulatory process, including the timely processing of relevant regulatory submissions.

C.18.1 Qualified Person’s declaration concerning GMP compliance of active substance manufacture “The QP declaration template”

A QP declaration is required to be submitted with all applications for new marketing authorisations, renewals and submissions of relevant quality variations, concerning changes (addition or replacement) to the manufacturer of a starting material and/or to the registered manufacturer(s) of the active substance, finished product or batch importation/certification sites. The use of the QP declaration template is optional. Nevertheless, applicants are strongly recommended to use the template to facilitate the validation of regulatory submissions and their review.

Chapter D: USA: CFR and FDA Guidelines

D.1 Code of Federal Regulations

The Code of Federal Regulations is subject to an annual revision. With the current Update of the GMP MANUAL we provide the recent versions of

  • 21 CFR 210 (chapter D.1.1)
  • 21 CFR 211 (chapter D.1.2)
  • 21 CFR 11 (chapter D.1.3)
  • 21 CFR 4 (chapter D.1.5)
  • 21 CFR 600 (chapter D.1.6)
  • 21 CFR 606 (chapter D.1.7)

The date of these CFRs has been updated as of April 1, 2014. No further amendments were made.

  • 21 CFR 820 (chapter D.1.4)

The list of definitions of 21 CFR 820 was extended.

Chapter F: PIC/S Guidelines

F.9-F.12 PIC/S PE 009-11: Guide to Good Manufacturing Practice for Medicinal Products

The changes made to the PIC/S GMP Guide take over the issues resulting from the transposition of the EU GMP Guide to the PIC/S GMP Guide and ensure a better harmonisation of the documents. In Part II a new subsection 2.2 has been added to section 2 Quality Management in order to introduce the principles of Quality Risk Management. Annex 2 regarding biological medicinal products for human use has been amended and Annex 14 regarding products from human blood or human plasma has been revised.

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