IPEC Releases Updated Risk Assessment Guide for Excipient Manufacturers

In May 2025, IPEC Europe announced the release of Version 1 of its revised Risk Assessment Guide for Pharmaceutical Excipients, now available to members via the IPEC website. The guide, expected to be publicly released by mid-2025, replaces the 2017 edition and is now an official IPEC Federation Document.

The updated guide provides a structured framework for excipient manufacturers to assess and manage risks. It includes chapters on risk assessment principles, methods, and manufacturer-specific practices. Key sections are: Introduction, Risk Assessment Principles, Methods, Manufacturer Risk Assessment, and References.

The current table of contents and a summary are accessible on the IPEC site, with the full version to follow in the “Guidelines” section under Resources.

30-06-2025