Annex 22 draft: artificial intelligence in GMP
What the draft EU GMP Annex 22 asks of AI models used in critical GMP applications, and how to record and assess them before it applies.
A new annex for a new kind of system
Annex 22 is new: there is no predecessor. The draft was published for consultation on 7 July 2025 together with the revised Annex 11. It is meant for AI models used in computerised systems in GMP where they have a direct impact on patient safety, product quality or data integrity, and it builds on Annex 11 rather than replacing it.
What the draft asks
The draft focuses on models whose behaviour is fixed once they are trained and which give the same output for the same input. Models that keep learning in operation, and generative models, are not to be used in critical GMP applications under the draft.
- A documented intended use, with the process, the input data and the decisions the model supports
- Acceptance criteria defined before testing, at least as good as the process the model replaces
- Test data independent of the training data and representative of the intended use
- Explainability and a confidence measure where the output needs a human decision
- Change control for the model and its data, and monitoring of its performance in operation
Why start now
AI features arrive through suppliers: a vision system in packaging, anomaly detection in a monitoring tool, classification in a document system. Recording where models are used, what they decide and how they were tested is the first step, whatever the final text says.
With the GxP Validation Assistant
How the assistant covers it
AI use cases by level
Each AI use is recorded and classified by AI level, from productivity use outside GxP to a critical GMP impact; the level sets the evidence and controls it needs.
The draft as a rule pack
Annex 22 is a rule pack labelled DRAFT, used with the AI and drafts overlays, that the use case and the risk assessment refer to.
Evidence package
Intended use, data, acceptance criteria, test results, human oversight and monitoring come together in one evidence document.
The AI Act alongside
With the AI overlay, the AI Act's obligations for companies that use AI systems are included as information.
Annex 22 is a draft and advisory until adopted. Rule texts are summaries in the product's own words with their sources.
See it with your own systems.
Watch the webinar, or install the assistant and try it for 14 days.