Most Frequently Asked Questions On The Revised EU GMP Annex 1: Volume 3

Find an essential overview of the EU GMP Annex 1 revision for sterile medicinal products, which took effect in August 2023. This revised guideline impacts not only the European Union and the UK but also any manufacturer globally exporting to these regions. Understanding the major changes is crucial for compliance. The revision places a significantly greater emphasis on a comprehensive Contamination Control Strategy (CCS) that must cover the entire end-to-end manufacturing process. Key updates also include expanded guidance on using Restricted Access Barrier Systems (RABS) and isolators, stricter requirements for continuous environmental monitoring, and detailed cleanroom design specifications that emphasize airflows. Additionally, the guidelines reinforce the need for robust personnel training and gowning procedures, recognizing that human intervention is a primary contamination risk. Gain a clearer understanding of the compliance requirements, the role of component suppliers, and how RABS and isolators can enhance your contamination control.

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