WHO TRS (Technical Report Series) 957, 2010 Annex 5

WHO TRS (Technical Report Series) 957, 2010 Annex 5

WHO good distribution practices for pharmaceutical products

1. Introduction:

Distribution is an important activity in the integrated supply-chain management of pharmaceutical products. Various people and entities are generally responsible for the handling, storage and distribution of such products. In some cases, however, a person or entity is only involved in and responsible for certain elements of the distribution process. The objective of these guidelines is to assist in ensuring the quality and identity of pharmaceutical products during all aspects of the distribution process. These aspects include, but are not limited to, procurement, purchasing, storage, distribution, transportation, repackaging, relabelling, documentation and record-keeping practices.

The storage, sale and distribution of pharmaceutical products are often carried out by various companies, institutions and individuals. This document sets out appropriate steps to assist in fulfilling the responsibilities involved in the different aspects of the distribution process within the supply chain and to avoid the introduction of counterfeits into the marketplace via the distribution chain. The relevant sections should be considered by various participants as applicable to the particular role that they play in the distribution of pharmaceutical products.

The nature of the risks involved is likely to be similar to that for risks encountered in the manufacturing environment, e.g. mix-ups, adulteration, contamination and cross-contamination. When the distribution chain is interrupted by manufacturing steps such as repackaging and relabelling, the principles of good manufacturing practices (GMP) should be applied to these processes.

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Table of Contents

1. Introduction

2. Scope of the document

3. Glossary

4. General principles

5. Regulation of the distribution of pharmaceutical products

6. Organization and management

7. Personnel

8. Quality system

9. Premises, warehousing and storage

10. Vehicles and equipment

11. Shipment containers and container labelling

12. Dispatch and receipt

13. Transportation and products in transit

14. Documentation

15. Repackaging and relabelling

16. Complaints

17. Recalls

18. Returned products

19. Counterfeit pharmaceutical products

20. Importation

21. Contract activities

22. Self-inspection


WHO TRS (Technical Report Series) 957, 2010 Annex 5

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