Bridging Guidance and Regulation: Interpreting the Draft Annex 22 on Artificial Intelligence in GMP Manufacturing

Abstract

This paper builds upon Stassen et al. (2025), "Recommendations for Artificial Intelligence Application in Continued Process Verification," to provide a detailed interpretation of the European Medicines Agency (EMA) Draft Annex 22 - Artificial Intelligence (July 2025 draft) - within the context of GMP-regulated pharmaceutical manufacturing. The draft annex introduces a structured, risk-based framework for AI adoption, defining expectations for intended use, validation, lifecycle management, explainability, and human-in-the-loop (HITL) oversight. This manuscript examines the alignment between Annex 22 provisions and CPV recommendations, identifies convergence, operational challenges, and areas for future development, and proposes a roadmap for compliant AI implementation. Conceptual frameworks and workflow illustrations depict the harmonization of CPV principles, lifecycle management, and emerging regulatory expectations. This review supports harmonized AI governance and readiness for Annex 22 compliance across the pharmaceutical sector.

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