Revision and publication of the GDP Guide 2017
The International Pharmaceutical Excipients Council (IPEC) is an international industry association with a distinguished worldwide membership of chemical, pharmaceutical and food organisations that develop, manufacture, distribute, sell and use pharmaceutical excipients.
Good Distribution Practice (GDP) is an important element in the supply chain management of pharmaceutical starting materials. During the past years there have been several incidents caused by the lack of a robust supply chain regarding security and the inappropriate handling and management of pharmaceutical excipients. These incidents have prompted regulators, users, manufacturers and distributors of these materials to take action to tighten up controls within the supply chain.
It is recognised that the IPEC GDP Guide was first published in 2006 and in need of alignment with current requirements and practices.
The IPEC Europe GDP Committee worked on revising the current IPEC guide, offering a practical approach with examples that provide guidance on the application of the WHO Good Trade and Distribution Practices principles, itself recently revised. To maintain consistency where GMP related activities are described, reference has been made to The Joint IPEC - PQG Good Manufacturing Practices Guide 2006 and other publications, such as the EXCiPACT™ Certification Standards for Pharmaceutical Excipient Suppliers Good Manufacturing Practices: Good Distribution Practices (2012).
The guide applies to steps in the distribution/supply chain starting from the point at which an excipient is transferred outside the control of the original manufacturer's material management system.
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