Validation And Qualification Approach Outlined In New Annex 1 Revision

By Serena Steidl, Advisory Specialist, Particle Measuring Systems

The 2022 revision of the EU GMP Annex 1 significantly enhances the guidelines for validating and qualifying sterile drug products, expanding from 16 to 59 pages. This comprehensive update underscores the critical importance of contamination control strategies, cleanroom classification, and personnel gowning, thereby ensuring product integrity and minimizing contamination risks. The revision clarifies the distinction between validation—ensuring processes yield expected results—and qualification, which confirms equipment functionality.

The revised guidelines advocate for a structured validation approach, detailing various methodologies, including traditional and continuous verification. Additionally highlighting that there is a necessity to identify critical quality attributes (CQAs) and critical process parameters (CPPs) to uphold product quality. The white paper outlines a systematic qualification process for equipment, utilities, and cleanroom environments and essential phases such as Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).

For professionals in the pharmaceutical industry, this revision not only provides a robust framework for compliance but also enhances understanding of product and process interactions. Access the full white paper to learn more.