IPEC: Updated Qualification-Guide published

IPEC Europe (International Pharmaceutical Excipients Council Europe) has published the updated Version 3 of the “Qualification of Excipients for Use in Pharmaceuticals: Guide & Checklist” on its website. First published in 2008, this guide provides recommendations for good practices in a risk-based process for qualifying excipients from new or existing suppliers. It supports the establishment of effective relationships between suppliers and users, facilitates the smooth use of excipients, and helps ensure compliance with regulatory and GMP requirements. The guide includes a checklist for identifying the essential information required to qualify excipients used in medicinal products.

Additional Section on Nitrosamines

The key substantive change in Version 3 (2026) compared with Version 2 (2020) is the inclusion of a dedicated section on nitrosamines (2.4.6.5). This section clarifies that nitrosamine risk assessments for finished medicinal products should take excipients into account, even where there is no explicit regulatory obligation for excipient manufacturers to test for nitrites or nitrosamines or to communicate relevant data. Version 3 also refers to an IPEC Nitrosamines Template to support the exchange of information.

The complete document is available on the IPEC website and can be downloaded after registration.