IPEC Updates Two Guides on Pharmaceutical Excipients
The IPEC Federation has updated two key guides on pharmaceutical excipients. The IPEC Composition Guide for Pharmaceutical Excipients (Version 3, 2026) describes an approach for manufacturers to establish excipient composition profiles. The revised version now covers biotechnology- and fermentation-derived excipients, provides further details on component types and physicochemical characterisation, and includes an example composition profile template.
IPEC has also published Version 3 of its Qualification of Excipients for Use in Pharmaceuticals Guide and Checklist. The guide has been aligned with current regulatory expectations and outlines best practices for qualifying excipients and their suppliers. The accompanying checklist provides a concise overview of the topics to be considered when qualifying an excipient for use in medicinal products.
Both guides were initially be available exclusively to IPEC members for a three-month period. They are now publicly available.
Source:
IPEC Europe: Guidelines
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