Regulatory guidance / GMP guideline
Proposed Annex 11 and Annex 22
Proposed computerised-system and AI controls for pharmaceutical GMP manufacturing.
Proposal / consultation history. Consultation closed 7 October 2025. These proposals have no established application date. Read the operative Annex 11 guide.
Open official sourceDoes this apply to my work?
Closed consultation is not adoption. The Commission still lists January 2011 Annex 11 as operative; use that source for current Annex 11 work.
Consultation closed 7 October 2025. These proposals have no established application date.
What does it address?
Proposals concern lifecycle oversight, data governance and AI model controls.
What does this mean in practice?
The controls and evidence below are practitioner examples. They are not mandatory document names or a complete list of obligations.
| Source provision | Requirement or recommendation | Practical control or activity | Example evidence | Applicability note |
|---|---|---|---|---|
| Proposed Annex 22 | Proposal, not an operative requirement | Identify AI uses and readiness questions separately from current obligations. | Clearly labelled gap analysis against draft proposals. | Do not call draft-based readiness work Annex 22 compliance. |
Illustrative example
A decision in practice
- Intended use
- A pharmaceutical site considers an AI model for manufacturing review.
- Risk
- A team might mistake a consultation proposal for an adopted requirement.
- Control
- Maintain separate current-obligation and proposal-readiness lists.
- Testing
- Check each claimed requirement against the applicable official publication.
- Evidence
- Dated source comparison and a labelled readiness plan.
- Conclusion
- The illustrative plan supports preparation without asserting that the draft is legally in effect.
More practitioner context
Practical impact
Use the drafts to identify potential readiness questions without representing them as current law.
Actions to consider
Map potentially affected controls and monitor official adoption. Label any resulting action as readiness work or professional interpretation.
Practitioner interpretation
Do not claim Annex 22 compliance or certification while the text remains a consultation draft.
Continuing context
Consultation text is not final binding or operative guidance. Existing applicable requirements continue until formally replaced.
Source and review information
Source check: 21 September 2026. Publication identity, scope and status checked against the linked official source. This is not an independent audit of every retained guide statement.
Citation, dates and editorial history
- Stable source ID
- eu-gmp-annex-11-annex-22-consultation
- Official citation
- Consultation: revised GMP Chapter 4, Annex 11 and new Annex 22
- Issuing organization
- European Commission
- Edition
- 2025 consultation drafts
- Publication
- 7 July 2025
- Application / transition
- Consultation closed 7 October 2025. These proposals have no established application date.
- Publication status
- Draft / consultation
- Verification
- Verified — public source metadata and scope
- Editorial update
- 21 September 2026 · Version 2.0
- Source owner
- CSVtoCSA editorial
- Review needed
- Recheck when the source or intended use changes
- Independent review
- No independent regulatory review is claimed.
- Prior editorial date
- 12 September 2026 (existing record or detailed guide)
21 September 2026: Source metadata checked, scope clarified, practical mapping and illustrative example added, and layout reorganized. Existing detailed guide content and its dated history are retained below its disclosure. This is an editorial update, not a regulatory amendment.
Questions and corrections
Contributor opinions are moderated and remain distinct from the source and site explanation. Comments do not update source metadata.
Suggest a source correction
Sent privately to the editorial moderation queue. Your account email and correction are not published as a comment. Do not include confidential or personal information.
Source: eu-gmp-annex-11-annex-22-consultation
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