Annex 22 and AI in validation documentation
Status: a draft, not a regulation
Annex 22 is a draft annex to EU GMP, published for public consultation on 7 July 2025; the consultation closed on 7 October 2025 and the final text has not been adopted, so it is not yet a basis for inspection. EU GMP Annex 22 (draft), consultation 7 Jul – 7 Oct 2025
Its scope covers artificial intelligence and machine learning models used in processes that affect product quality or patient safety; general computerised systems in regulated manufacturing remain under Annex 11. EU GMP Annex 22 (draft), scope; EU GMP Annex 11
What it expects from AI-assisted documentation
The draft of Annex 22 expects a defined intended use for the model, documented validation and change control, human oversight of outputs, and transparency about the data involved. EU GMP Annex 22 (draft, 7 Jul 2025)
Translated into documentation practice: an AI output is a draft until a qualified person has reviewed it, and the review itself must be recorded — who reviewed, when, and what changed. If your quality system has no procedure for the use of AI, write one before the first project, not after.
How to stay aligned before the final text
US enforcement already points the same way: the first FDA warning letter to cite the misuse of artificial intelligence in drug manufacturing (2 April 2026) required human review and approval of every AI output used in cGMP activities. The firm, despite its name, manufactured drug products and was held to drug cGMP. FDA Warning Letter — Purolea Cosmetics Lab, 2 April 2026 (CDER)
Teams using models in quality-critical processes today should document their decisions as if the requirement were already in force: the rationale for the model, the inputs, the acceptance criteria, and the oversight after deployment. These are the decisions an inspector will ask about regardless of when the final text lands.
Tooling should make this easy rather than possible: a visible draft state, a recorded review, provenance of inputs and model. That is the rule Valready is built on — AI drafts the documentation, a human reviews every document before release, and AI never approves anything on its own; approval belongs to your Quality Unit in your QMS.
Frequently asked questions
Is Annex 22 already binding?
No. It is a draft published for consultation on 7 July 2025; the consultation closed on 7 October 2025 and the final text has not been adopted. General computerised-system requirements remain under Annex 11. EU GMP Annex 22 (draft); EU GMP Annex 11
What tool keeps validation documentation aligned with Annex 22 expectations for AI?
Any tool used for AI-assisted documentation should enforce what the draft expects: a visible draft status, a recorded human review, provenance of inputs and model, and an audit trail. Valready implements this as a mandatory human review gate — AI never approves anything on its own.
Does Annex 22 replace Annex 11?
No — it supplements it. Models affecting product quality or patient safety fall under the new draft; the general requirements for computerised systems stay where they are. EU GMP Annex 22 (draft), scope; EU GMP Annex 11