What they are and where they stand
EudraLex Volume 4 is the EU guide to good manufacturing practice. Its annexes add detail for specific topics. Three matter most for US exporters, and a fourth is on the way.
| Annex | Topic | Current status |
|---|---|---|
| Annex 1 | Manufacture of sterile medicinal products | Revised version (file dated 25 August 2022) fully applicable since 25 August 2024 |
| Annex 11 | Computerised systems | Version dated January 2011 still in force; revision in progress |
| Annex 15 | Qualification and validation | In operation since 1 October 2015; revision planned |
| Annex 22 (new) | Artificial intelligence | Draft only; not in force |
The AI-era rewrite. From 7 July to 7 October 2025 the Commission consulted on three linked drafts: a revised Chapter 4 (documentation), a revised Annex 11, and a new Annex 22 on AI and machine learning. The drafts were prepared by EMA’s GMDP Inspectors Working Group with PIC/S. Draft Annex 22 covers defining a model’s intended use and performance metrics, training and test data quality, and ongoing oversight through change control, performance monitoring, and human review.
According to an August 2026 review of the EU GMP work plan, a two-day expert workshop on 30 June and 1 July 2026 discussed a risk-based approach to generative AI, and final texts for Annex 11, Chapter 4, and Annex 22 are targeted for Q4 2026. Annex 15 and Chapter 1 revisions share that target. These are planning targets, not adoption dates. As of 26 October 2026, the Commission’s Volume 4 page still lists the 2011 Annex 11 and Chapter 4.
Where to find it
- European Commission EudraLex Volume 4 page: Parts I to IV, the annexes, and a “latest updates” list.
- Commission consultation page for the Chapter 4, Annex 11, and Annex 22 drafts.
- PIC/S, whose GMP guide mirrors EU annexes closely (see the PIC/S article).
Reuse terms
Commission website content is generally licensed under CC BY 4.0 unless otherwise indicated, under the 2011 Commission reuse decision. You may reuse it, including commercially, if you credit the source and indicate changes. Logos and third-party material are excluded. Referenced ISO or ICH documents keep their own terms.
Using EU GMP annexes in AI and RAG
- Store each annex with its version date and “in force” status. Annex 11 should say “January 2011, in force; revision pending.”
- Keep the 2025 drafts in a separate “draft” collection. They are useful for gap planning, but not current requirements.
- Add CC BY attribution and a “modified” note when your outputs summarize or excerpt the text.
- Link Annex 11 to US Part 11 in your index so dual-market answers cite both, each as its own jurisdiction.
- Watch the Volume 4 “latest updates” list and re-index when final texts are published.
- If you use AI in GMP operations yourself, read draft Annex 22 now as a design guide, but do not cite it as binding.
Common mistakes
- Quoting draft Annex 11 or Annex 22 as current requirements.
- Forgetting that Annex 1 has been fully applicable since August 2024, including the provisions that were deferred.
- Dropping CC BY attribution in summaries.
- Treating the PIC/S version as identical in every detail without checking.
Checklist
- Each annex stored with version date and status
- 2025 drafts in a separate, labeled collection
- Attribution and “modified” notice in outputs
- Linked to equivalent US requirements
- Volume 4 updates monitored
- Internal AI use reviewed against draft Annex 22
How AskDona helps
AskDona compares your contamination control strategy, CSV procedures, and validation master plan with Annex 1, Annex 11, and Annex 15. It can also run a forward-looking gap check against the 2025 drafts, clearly marked as draft, so you can plan before final texts land.
Run a sample Annex 11 gap check
AskDona shows the evidence; your QA team decides.
Editor’s note. This article is general information, not legal advice. The “CC BY 4.0, conditional use” rating comes from our source list and is a first-pass judgment, not a legal opinion.
FAQ
Is Annex 22 in force? No. It was a consultation draft in 2025. A final text is targeted for Q4 2026, but no adoption date has been set.
Which Annex 11 applies today? The January 2011 version, until a revised text is adopted and takes effect.
Since when is the revised Annex 1 fully applicable? 25 August 2024.
Can I use EU GMP text in a commercial AI tool? Generally yes under CC BY 4.0, with attribution and a note of changes. Third-party material and logos are excluded.
References
All pages opened and checked by October 26, 2026.
| Source | What it supports |
|---|---|
| European Commission: EudraLex Volume 4 | Structure, Annex 1 applicability, Annex 11 and Chapter 4 dates, Annex 15 date |
| Commission consultation: Chapter 4, Annex 11, Annex 22 | Consultation dates and scope of drafts |
| MFLRC: EU GMP guide revisions 2026–2028 (Aug 24, 2026) | Q4 2026 targets, June 2026 workshop |
| European Commission legal notice | CC BY 4.0 reuse and exclusions |