IPEC Europe Releases 2025 Risk Assessment Guide for Excipient Manufacturers

The International Pharmaceutical Excipients Council Europe (IPEC Europe) has announced the public release of “IPEC Risk Assessment Guide for Pharmaceutical Excipients – Risk Assessment for Excipient Manufacturers (Version 1, 2025)”. Previously accessible only to members since May 2025, the guide is now available under the “Resources” → “Guidelines” section of the IPEC website.

Version 1 outlines a structured approach for excipient manufacturers to evaluate and manage risks, with key chapters including: Acknowledgements, Introduction, Principles of Risk Assessment and Management, Risk Assessment Methods, Risk Assessment by Excipient Manufacturer, and References. Chapters 1, 2, and 4 are further divided into detailed subchapters and subsections.

The guide is intended to help manufacturers align with industry best practices, ensure compliance with regulatory expectations, and strengthen quality management systems. The complete document can be accessed directly from the IPEC Europe website.

11-08-2025