EU GMP Guide: Chapter 4, Annex 11 and New Annex 22
The EC has published the long-awaited revised and new documents of the EU GMP Guide for consultation: Chapter 4 Documentation, Annex 11 Computerised Systems and the new Annex 22 Artificial Intelligence. Stakeholder consultations are open until 7 October on the EC website.
Revision of Chapter 4 – Documentation
The updated Chapter 4 emphasises the critical role of documentation in GMP and supports the use of digital, hybrid, and emerging technologies. Risk-based data governance is now a core element to ensure document accuracy, integrity, availability, and legibility across all formats. It also clarifies requirements for managing electronic records, signatures, and data integrity, aligning with the ongoing revision of Annex 11.
Revision of Annex 11 – Computerised Systems
The updated Annex 11 reinforces lifecycle management of computerised systems, requiring comprehensive application of Quality Risk Management. It strengthens requirements for system specifications, supplier oversight, data integrity, audit trails, electronic signatures, and security.
New Annex 22 – Artificial Intelligence
Annex 22 sets out requirements for the use of AI and machine learning in the manufacture of active substances and medicinal products. It covers model selection, training, validation, and performance monitoring. Key areas include intended use, data quality, performance metrics, change control, and human oversight.
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