EU GMP Annex 22 (draft): status and scope
What status it has
Annex 22 is a draft annex to EU GMP and was published for public consultation on 7 July 2025. EU GMP Annex 22 (draft), published for consultation 7 July 2025
The public consultation closed on 7 October 2025, and the document remains a draft that is not yet binding. EU GMP Annex 22 (draft), public consultation closed 7 October 2025
The draft is not a basis for inspection, but it is the best available signal of what an inspector will expect once the text becomes binding. That is reason enough to read it now rather than after the final version is published.
What it covers
The scope of draft Annex 22 covers artificial intelligence and machine learning models used in processes that affect product quality or patient safety. EU GMP Annex 22 (draft), scope
General requirements for computerised systems in regulated manufacturing remain within the scope of Annex 11. EU GMP Annex 11 — Computerised Systems
What it means in practice
Teams already deploying models in processes that affect product quality should document their decisions as if the requirement applied. The rationale for choosing the model, the training data, the acceptance criteria and oversight of performance after deployment are things they will have to defend to an inspector either way.
Frequently asked questions
Is Annex 22 in force yet?
No. Annex 22 remains a draft: it was published for public consultation on 7 July 2025, the consultation closed on 7 October 2025, and no final text has been adopted. General requirements for computerised systems still come from Annex 11. EU GMP Annex 22 (draft, 7 July 2025); EU GMP Annex 11
How does the scope of Annex 22 differ from Annex 11?
Draft Annex 22 covers artificial intelligence and machine learning models used in processes that affect product quality or patient safety. General computerised systems in regulated manufacturing remain within the scope of Annex 11. EU GMP Annex 22 (draft), scope; EU GMP Annex 11
Is it worth following the draft before it becomes binding?
Yes — the draft is the best available signal of what an inspector will expect. Teams deploying models in quality-critical processes should already document the rationale for choosing the model, the training data, the acceptance criteria and post-deployment oversight.