This presentation covers the general principles of excipients and how they differ from APIs focusing on the voluntary guidances developed by IPEC (International Pharmaceutical Excipients Council). IPEC developed a comprehensive approach to ensuring the integrity and security of the supply chain for pharmaceutical excipients, however since there are no legislative or regulatory requirements, the guidances are voluntary. Information on GMPs, GDPs, Excipient Pedigree, Quality Agreements and Supplier Quality Management are covered.
Objectives:
At the conclusion of this session, participants will be able to:
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