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


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Updates Forecast & History


GMP MANUAL Update No. 16


GMP in Practice (File 1–5)

Chapter 19 Quality Unit

19.I Fight against counterfeit medicines

In the age of globalisation and the World Wide Web (Internet) counterfeit medicines have grown to become a serious challenge. Not only growth markets, but also all other markets are affected globally. This problem is a matter of grave concern to manufacturers of branded and generic products alike, parallel importers and wholesalers, brokers, and all others involved in the distribution chain of medicinal products. Therefore, as part of an effective risk management system, particularly with regard to mitigating the risks associated with medicinal products, both pharmaceutical companies and other participants in the supply chain of medicinal products will have to adequately address this topic. The author demonstrates how the fight against counterfeit medicines can be organized in a model process consisting of monitoring, knowledge building, prevention and reaction (Dr. Stephan Schwarze).

Chapter 24 Transport


The production of high-quality, safe medicinal products is the declared objective of every pharmaceutical company and is subject to GMP rules. Even though a medicinal product may be of impeccable quality when it leaves the manufacturing facility, during transport to the end consumer it is exposed to many influences that are beyond the control of the manufacturer and that are capable of permanently compromising the quality of the product. Therefore, it is not surprising that “pharmaceutical transport” or carriage in accordance with “good distribution practice” has recently become a topic of steadily growing importance. This change in awareness can be observed in inspections by authorities and in the quality assurance departments of pharmaceutical companies alike.

This comprehensive chapter provides detailed and practical information on numerous topics related to transportation of pharmaceutical products, focussing on ensuring product quality.

The importance of Good Distribution Practice and Supply Chain Integrity for ensuring drug product quality up to the end user is explained in chapter 24.A Introduction. Relevant national and international Guidelines are presented in chapter 24.B Regulatory principles, where the focus is laid on the current EU GDP Guidelines and the new monograph <1079> on Good Storage and Distribution Practice of USP 36. The concept of transport as mobile storage is introduced in chapter 24.C Transport conditions. Special conditions for ambient, refrigerated and frozen transports are explained. Different kinds of transport vehicles and transport packaging are dealt with in chapter 24.D. A fundamental distinction has to be made between active and passive temperature control in this context. Active vehicles for overland transport, shipping containers for air cargo and different types of passive transport packaging are described and their pros and cons discussed. Guidelines and quality standards for land and air transportation are subject of chapter 24.E Modes of transport. Provisions of the ATP Agreement and the IATA Regulations are introduced and discussed in detail. In order to assure product quality during transport, temperature monitoring is imperative. Various approaches such as loggers, RFID technology and telematics are presented in chapter 24.F Monitoring. Potential risks during transport and the benefits of applying risk management in order to control them are discussed in chapter 24.G Risk management in transportation. Under the aspect of medicinal product quality, a risk-based approach can be used to determine the scope and depth of qualification and validation activities. This approach is described in chapter 24.H Qualification of large-scale active systems and 24.I Qualification of thermal shipment packaging. Relevant criteria for operational and performance qualification such as temperature mapping, temperature profiles and loading patterns are discussed in detail. In Chapter 24.J, responsibilities of Logistics service providers are explained and a requirements profile is derived from this. Critical aspects of various distribution methods are highlighted, taking cold chain logistics as an example. As with other service providers in the field of pharmaceuticals, logistic service providers need to be qualified. A comprehensive list of questions for preparing an initial audit is included. The drawbacks and opportunities of Transport Validation are addressed in chapter 24.K. Whereas it seems possible to validate separate segments of the transport chain, as shown for the validation of a cold chain as an example, the validation of a global transport chain represents an enormous challenge which is almost impossible to overcome. (Dr. Christoph Frick, Dr. Nicola Spiggelkötter)

24.L Good Distribution Practice Checklist

Chapter 24.L Good Distribution Practice Checklist offers a comprehensive GDP audit checklist for the storage and transport of drugs. This convenient document contains questions typically asked during inspections and audits and helps navigating through planning, preparing and carrying out self-inspections and audits with a focus on Good Distribution Practice (GDP). The checklist covers the entire life cycle of the finished pharmaceutical product, from the manufacturer’s premises to the pharmacy shelf. For each question, the audit checklist includes a reference to relevant guidelines and standards, including the EU GDP Guidelines and EN ISO 13485. (Simone Dietz)

GMP Regulations (File A–D)

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 the following Parts as of April 1, 2013:

  • Part 210 (chapter D.1.1)
  • Part 211 (chapter D.1.2)
  • Part 11 (chapter D.1.3)
  • Part 820 (chapter D.1.4)

Only minor amendments were made to 21 CFR 210, 211 and 820, mainly the correction of spelling errors. 21 CFR 11 remains unchanged.

D.18 Guide to Inspections of Quality Systems

This document provides guidance to the FDA field staff on an inspectional process that may be used to assess a medical device manufacturer’s compliance with the Quality Systems Regulation and related regulations. This inspectional process is known as the “Quality System Inspection Technique” or “QSIT”. Field investigators may conduct an efficient and effective comprehensive inspection using this guidance material which will help them focus on key elements of a firm’s quality system.

Chapter F: PIC/S Guidelines

F.9–F.12 PIC/S PE 009-10: Guide to Good Manufacturing Practice for Medicinal Products

Originally the PIC/S GMP Guide derives from the WHO GMP Guide and was further developed in order to comply with stringent manufacturing and health requirements in PIC/S countries, to cover new areas and to adapt to scientific and industrial technology. The PIC/S GMP Guide is almost identical with the EU GMP Guide. Both guides have been developed in parallel. Therefore, the revisions in the PIC/S Guide correspond with the recent changes in the EU GMP Guide.

The revised PIC/S GMP Guide entered into force on 1 January 2013. Affected by the revision were the following parts:

  • PIC/S PE 009-10 – Intro (chapter F.9)
  • PIC/S PE 009-10 – Part I (chapter F.10)
  • PIC/S PE 009-10 – Part II (chapter F.11)
  • PIC/S PE 009-10 – Annexes (chapter F.12)

The document history was updated in the Intro. In Part I, Chapter 4 (Documentation) has been amended. The Annexes 6 Manufacture of Medicinal Gases, 7 Manufacture of Herbal Medicinal Products, 11 Computerised Systems and 13 Manufacture of Investigational Medicinal Products were updated.

F.17 PIC/S PE 005-3 – GMP Guide for Blood Establishments

The purpose of this PIC/S document is to provide guidance for GMP inspectors to use during inspections of blood establishments. It gives an insight into the thinking and concerns of inspectorates. Useful information is included relating to the collection, preparation, storage, dispatch, quality control and quality assurance of blood and blood components.

F.18 PIC/S PI 012-3 – Recommendation on Sterility Testing

Inspection of sterility testing facilities and test methodology used by laboratories performing the sterility test for batch release of pharmaceutical products is included in the quality control activities checked by GMP inspectors. This recommendation provides guidance for GMP inspectors to use for training purposes and in preparation for inspections in order to promote a consistent and thorough approach in all aspects of sterility testing.

F.19 PIC/S PI 014-3 – Recommendation on Isolators Used for Aseptic Processing and Sterility Testing

The term “isolator” as used in the Pharmaceutical Industry covers a variety of types of equipment. This recommendation addresses only isolators that are subjected to a sporicidal process (usually delivered by gassing) as they are the most frequently found types in licensed industrial facilities. The document provides guidance for GMP inspectors to use for training purposes and in preparation for inspections of isolators subjected to a sporicidal process used for aseptic processing and sterility testing.

F.20 PIC/S PI 024-2 – Aide-mémoires - Inspections of Biotechnology Manufactures

The Aide-mémoires were drafted with the aim of facilitating the effective planning and conducting of GMP inspections. Their purpose is to provide a tool for harmonization of GMP inspections and to assure the quality of such inspections. The document applies to biotech products and classical biological products for human use, but could also be used for gene-therapy and cell-therapy products.

F.21 PIC/S PI 025-2 – Aide-mémoire – Inspections of Medicinal Gases

This Aide-mémoire was prepared to enable the effective planning and conducting of GMP inspections of manufacturing of medicinal gases. It describes three different types of manufacturing: air separation units, filling stations and the manufacturing of medicinal gases in hospitals. Focus is put on the special needs regarding this area.

Chapter G GMP of Other Regions

This chapter is supplied on CD-ROM and online only.

The following GMP regulations have been added:

  • G.5 Indian GMP Regulations
  • G.6 Australian GMP Regulations
  • G.7 Brazilian GMP Regulations
    (including a detailed analysis of the current Brazilian GMP guidelines)

Important Information

GMP MANUAL Paper Version will be discontinued – Go Online NOW!

Based on the ever changing GMP guidelines and requirements the GMP MANUAL has been updated twice a year up to now. However, the flexibility of an online database better serves the need of reliable up-to-date information. Therefore this Update 16 is the last insert into the GMP MANUAL paper binders. As of now, the GMP MANUAL will be continued as online version. Alternatively, a CD ROM will also be available.

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