Good Distribution Practice and Cold Chain Management – Current Regulatory Initiatives

GMP News No. 419

GMP News
7 May 2004
 

Good Distribution Practice and Cold Chain Management –
Current Regulatory Initiatives

 
The GMP principles for the manufacture, packaging and storage of active pharmaceutical ingredients and medicinal products are in many ways defined and interpreted by means of regulations, guidances and recommendations. For the GMP-compliant shipping of medicinal products, however, there are only few meaningful documents. Nevertheless, the pharmaceutical industry has been acting on a global scale for some time now. Therefore, the topic of GMP for the distribution practice plays an important role.

At the moment, there are 3 initiatives aiming at the creation of regulations for Good Distribution Practice and at the definition of corresponding standards. One of these initiatives was triggered by the PDA (Parenteral Drug Association). In the middle of 2002, PDA brought the 'Pharmaceutical Cold Chain Discussion Group' (PCCDG) into being. This body is working on a guideline on GMP-compliant distribution practice for temperature-sensitive finished drug products, intermediates and APIs in close co-operation with its European equivalent, the 'Cold Chain Committee' (C3). This guideline describes specifications for primary and secondary packaging materials as well as the principles of shipping validation.

Another important initiative was started by USP. In the pharmacopoeial forum (issue Sept/Oct 2003), the draft of the informational chapter '<1079> Good Storage and Shipping Practices' was published for commenting for a period of 6 months. This document is directed at manufacturers of medicinal products, repackagers, distributors, shippers, and pharmacists, and deals with the following topics:

Storage area:

  • Establishing of temperature profiles
  • Storage at controlled RT - cool, cold, freeze storage
  • Regulations for the entry of goods

Distribution and shipping of medicinal products:

  • Cold chain management
  • Transport vehicles vehicle validation
  • Choice of packaging / channel of distribution
  • Implementation of standardised stress tests
  • Protection of fragile freight

At the beginning of this year, the WHO published a document titled 'Good Distribution Practices (GDP) for Pharmaceutical Products' for commenting until the end of March. This guidance contains regulations on the following points:

  • Quality management, organisation and personnel
  • Premises and storage areas
  • Transport vehicles, external packaging and labelling
  • Distribution and shipping practice, documentation
  • Repackaging and relabelling
  • Complaints, recalls and returned products
  • Imports and contracting

According to the schedule, this guidance is meant to be published for commenting a second time in June this year, and presented to the '39th WHO Expert Committee on Specifications for Pharmaceutical Preparations' in autumn.

This guidance is the counterpart of the document 'Good Trade and Distribution Practices for Pharmaceutical Starting Materials,' which was published in the WHO Technical Report Series in 2003. You can download it by clicking here.

By the way, at the European level, the EU 'Guidelines on Good Distribution Practice of Medicinal Products for Human Use' (94/C 63/03) dating back to 1992 form the official basis for inspections. (Click here to view the document.)

The initiatives presented above show that there is need for regulation in order to achieve GMP-compliant processes in distribution and shipping and that, on this topic, there will be relevant regulations to be observed in the future.  

Author:
Dr G. Becker
CONCEPT HEIDELBERG

 

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