Announcing the publication and availability of the revised IPEC GDP Guide in May 2017
The IPEC Federation Good Distribution Practices (GDP) for Pharmaceutical Excipients 2017 (To download go to Document Depot, under Resources)
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 will be officially available todownload on 16 May 2017 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 (WHO) “GOOD TRADE AND DISTRIBUTION PRACTICES FOR PHARMACEUTICAL STARTING MATERIALS” (WHO Technical Report Series, 996, 2016).
Where Good Manufacturing Practices (GMP) relevant activities are described, reference to The IPEC-PQG GMP Guide and other publications and standards, such as the EXCiPACT GMP and GDP standards (2012) and NSF/IPEC/ANSI 363 - 2016 GMP for Pharmaceutical Excipients Standard, are made in order to maintain consistency.
For the purpose of this document “distributors” includes for example, those parties involved in trade and distribution, re-processors, re-packagers, transport and warehousing companies, forwarding agents, brokers, traders, and suppliers other than the original manufacturer.
Finished drug product manufacturers seek to assure that all starting materials used in their products meet applicable quality and safety standards and are manufactured in accordance with current best industry practice. In order to achieve this they need a recognized quality approach such as this guide to communicate to their suppliers.
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