IPEC: Updated Qualification Guide

In April 2026, the International Pharmaceutical Excipients Council Europe (IPEC Europe) announced the updated Version 3 of the ‘Qualification of Excipients for Use in Pharmaceuticals: Guide & Checklist’ in a notice on its website. This guide was first published in 2008 and is currently only available in the IPEC members’ area. The updated guide, including the checklist, is expected to be published in full once a three-month period has elapsed (expected to be 9 July 2026). As usual, it is likely that this will be available under the 'Resources' section of the 'Guidelines' page on the IPEC website. Currently, the summary and table of contents can be viewed.

The table of contents for Version 3 of the updated guide includes the following chapters, with Chapters 1, 2, 3 and 4 containing further sub-chapters and sub-sections. You can find an overview of the main chapters and appendices here:

FOREWORD
ACKNOWLEDGEMENTS
1 INTRODUCTION
2 GENERAL GUIDANCE
3 EXCIPIENT DEVELOPMENT AND SPECIFICATION PROCESS
4 EXCIPIENT SELECTION CRITERIA
5 REFERENCES
ANNEX A - Qualification Check List

The advance notice of Version 3 of the ‘Qualification of Excipients for Use in Pharmaceuticals: Guide & Checklist’ and the full table of contents can be found on the IPEC website.