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GMP MANUAL Online - Interim Development - September 2013

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)

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.

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.

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