Publication of revised IPEC GDP Guide

Published: 18-May-2017

The IPEC Federation Good Distribution Practices (GDP) for Pharmaceutical Excipients 2017

The IPEC Federation has updated the IPEC GDP Guide, bringing the document in line with the latest thinking on GDP requirements for pharmaceutical excipients. The updated guide is now officially available to download from the following websites:

Excipients play a critical role in the manufacture of medicines by helping to preserve the efficacy, safety, and stability of active pharmaceutical ingredients (APIs) and help to ensure that they deliver their promised benefits to patients.

GDP is an important element in the supply chain management of pharmaceutical starting materials. Several incidents in the past were caused by a lack of supply chain security and inappropriate handling of pharmaceutical excipients. This has moved regulators, users, manufacturers and distributors to take action.

This revised guide supersedes the 2006 version and has been updated to provide guidance for those companies involved in the supply chain of pharmaceutical excipients and addresses more recent developments where an increasing emphasis is placed on risk and quality management.

Examples based on practical experience are provided to facilitate the application of GDP. However, alternative approaches may be acceptable.

It also provides additional explanatory notes to the World Health Organisation’s “Good Trade And Distribution Practices For Pharmaceutical Starting Materials” (WHO Technical Report Series, 996, 2016).

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