EU GMP Annex 22 Is Now in Force
What every EU pharma facility must have documented — aligned with GAMP 5 AI Guide.
EU GMP Annex 22 on Artificial Intelligence entered into force in March 2026. Every EU-licensed pharmaceutical manufacturer using AI systems is now subject to inspection against its requirements.
What Annex 22 Requires
Annex 22 requires AI systems used in GMP-regulated activities to follow a risk-based validation approach consistent with the ISPE GAMP AI Guide. Core requirements include: data governance documentation, pre-defined acceptance criteria, model version control, ongoing performance monitoring, and a change control procedure specific to AI model updates.
What Inspectors Are Looking For
Based on early inspection outcomes, EMA inspectors are focusing on four areas: evidence that acceptance criteria were defined before testing; model version control records with SHA-256 hashing or equivalent; an ongoing monitoring programme with defined performance KPIs; and change control records for all model updates since initial validation.