Quick answer Draft Annex 22 is the EU's proposed GMP guidance for data-trained AI and machine learning (AI/ML) models used in critical pharmaceutical manufacturing applications. It introduces AI-specific expectations for governance, validation, risk management, human oversight and ongoing monitoring, helping quality teams prepare for the safe and compliant use of AI in GMP-regulated environments. Introduction Ask a QA manager about their biggest challenge in 2026 , and AI comes up fast. Cameras inspecting vials. Models flag deviations before anyone opens the batch record. This has moved off the slide deck and onto the shop floor.