IPEC: Revised Risk Assessment Guide for Pharmaceutical Excipients

In May 2025, the IPEC (International Pharmaceutical Excipients Council Europe (IPEC Europe) asbl) announced the new version 1 of its "IPEC Risk Assessment Guide for Pharmaceutical Excipients - Risk Assessment for Excipient Manufacturers (Version 1, 2025)" on its website. It is currently only available and can be viewed in the IPEC member area. The updated guide is to be published after a period of three months (probably in mid-2025). It can be assumed that this will be available as usual under the "Resources" section in the "Guidelines" area of the IPEC website. The summary and table of contents of the new guide and the previous version, which was published in 2017 under the title "The IPEC Risk Assessment Guide for Pharmaceutical Excipients Part 1 - Risk Assessment for Excipient Manufacturers", can currently be viewed. According to the pre-announcement, the new guide is now an "IPEC Federation Document", whereas the 2017 guide was a joint draft of the "IPEC Americas" and "IPEC Europe Guide".

The table of contents of version 1 of the new guide from 2025 includes the following chapters, with chapters 1, 2 and 4 showing further sub-chapters and sub-items. The overview of the main chapters can be found here:

ACKNOWLEDGEMENTS
1 INTRODUCTION
2 PRINCIPLES OF RISK ASSESSMENT AND MANAGEMENT
3 RISK ASSESSMENT METHODS
4 RISK ASSESSMENT BY EXCIPIENT MANUFACTURER
5 REFERENCES

The pre-announcement of version 1of the "IPEC Risk Assessment Guide for Pharmaceutical Excipients - Risk Assessment for Excipient Manufacturers (Version 1, 2025)" as well as the complete table of contents can be found on the IPEC website.