Availability of the IPEC Risk Assessment Guide for Pharmaceutical Excipients – Risk Assessment for Excipient Manufacturers (Version 1, 2025).

The IPEC Risk Assessment Guide provides detailed guidance on evaluating risks to excipient quality, supporting excipient manufacturers and distributors in making consistent, risk-based decisions, and serves as a resource for excipient users assessing their suppliers’ risk strategies.

Key Risk Assessment methodologies and tools for identifying and mitigating quality-related risks are outlined; this document is essential to understand and apply effectively the risk assessment principles referenced in the IPEC-PQG GMP (Good Manufacturing Practices) and IPEC GDP (Good Distribution Practices) Guides for Pharmaceutical Excipients.