Glossary · GxP: good practices
EU GMP Annex 22 (artificial intelligence, draft)
Also known as: Annex 22, Draft Annex 22, EU GMP Annex 22 Artificial Intelligence
EU GMP Annex 22 is a draft annex to EudraLex Volume 4, published for consultation in July 2025 by the European Commission, EMA and PIC/S, on artificial intelligence and machine learning models used in computerized systems in the manufacture of medicines and active substances where they affect patient safety, product quality or data integrity. The draft is limited to static, deterministic models and excludes dynamic, continuously learning models and generative AI or large language models from critical applications.
- GxP
- Pharma
- EU
- AI
In one sentence
Draft EU GMP Annex 22 (July 2025) covers static, deterministic AI models in GMP-critical systems; check whether a final version has been adopted.
Example
A manufacturer plans an image-classification model to reject defective vials on a filling line; it applies the draft Annex 22 expectations by defining the intended use, setting acceptance criteria, testing on independent data and monitoring performance in operation.
How it applies
- Status: As of September 25, 2026 treat Annex 22 as a draft. It was published together with a revised Annex 11 and a revised Chapter 4 on documentation; check whether the final versions have been adopted. It is not applicable GMP law until then, though it indicates the direction of regulatory expectations.
- Scope: AI models in computerized systems used in GMP manufacturing where they affect patient safety, product quality or data integrity. Annex 11 continues to apply to the system as a whole.
- Model types: The draft covers static models with deterministic output. Dynamic models that keep learning in use, and generative AI or large language models, are excluded from critical applications.
- Expectations: The draft addresses topics such as intended use, acceptance criteria, independent test data, explainability and performance monitoring in operation, with change control for model updates; see AI drift.
- Technical documentation: Record the intended use, the data used for training and testing and their independence, the test results against acceptance criteria, and the operational monitoring plan, alongside the usual CSV documents.
Annex 22 vs. the AI Act
Annex 22 is a sector GMP expectation for AI used in manufacturing medicines, enforced through GMP inspections. The EU AI Act is horizontal product law; AI used for GMP quality decisions is not by that alone high-risk under it, and whether AI in manufacturing equipment falls under an AI Act route depends on the product law that applies, such as the Machinery Regulation. AI that is itself a medical device follows the MDR, IVDR and AI Act route described under AI in medical devices, not Annex 22.