Article | August 16, 2025

EU GMP Annex 1 Compliance: Global Requirements And PIC/S Alignment

Source: CAI
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The 2023 revision of EU GMP Annex 1 established a new global standard for sterile manufacturing by tightening contamination-control expectations and aligning requirements across key markets. To secure market access and pass regulatory inspections, manufacturers must now demonstrate clear, risk-based conformity with the new text. This article reviews the significant changes and explains how the Pharmaceutical Inspection Co-operation Scheme (PIC/S) has made the new requirements a global standard. It then delves into the three key pressure points emerging during inspections: a mandated Contamination Control Strategy (CCS), mandatory risk-based qualification, and the heightened focus on human performance. Finally, it outlines how you can address these challenges with a single, integrated program.

Read on to learn how to prepare your organization for the new requirements and avoid potential compliance risks.

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