EU GMP consultation drafts, 2025
Annex 11 and Annex 22 drafts: what changes
None of the three 2025 drafts is in force: on 18 October 2026 the 2011 Annex 11 and Chapter 4 still apply, and Annex 22 has not been adopted. The drafts still show clearly what EU and PIC/S inspectors expect of computerised systems, from cloud suppliers to alarms, logins and audit trails, so they are worth planning for now.
As of 18 October 2026 the European Commission's EudraLex Volume 4 page still lists the January 2011 Annex 11 and Chapter 4 and no Annex 22, so none of the three drafts has been adopted (source: European Commission, EudraLex Volume 4).
Annex 11 draft
What the draft Annex 11 adds to the 2011 text
The 2011 Annex 11 runs to 5 pages. The July 2025 draft runs to 19, in 17 sections, with whole new sections on supplier and service management, alarms, identity and access management, security and backup. These are the changes that matter most for anyone running a monitoring system.
Annex 11 draft §2.6, §7.1, §9.9
Using a SaaS supplier does not move your accountability
The draft says that relying on a vendor, a service provider or your own IT department does not change the requirements: the regulated user stays fully responsible, based on risk. You may use the supplier's validation documents, but you must review them and authorise their use for the version you actually run.
Annex 11 draft §8.1 to 8.7
Alarms get their own section for the first time
Where you rely on a system to tell you about an event, the draft expects alarms. Critical alarms should only be acknowledged by users with the right privileges, with a comment on why. Every alarm and acknowledgement goes into an automatic log (alarm name, times, user name and role, comment) that users cannot edit or switch off, and the log is reviewed periodically.
Annex 11 draft §11.1 to 11.11
Shared logins are called a data integrity violation
Every user should have a unique personal account; shared accounts are only acceptable if read-only. The draft also expects enforced password rules, MFA for remote access to critical systems from outside controlled perimeters, automatic lock-out after failed attempts, an inactivity logout users cannot switch off, a searchable access log, and documented recurring reviews of accounts and roles.
Annex 11 (2011) §9; Annex 11 draft §12.1 to 12.4
Audit trails move from 'consider' to 'should, always on and locked'
The 2011 text asks you to consider an audit trail based on risk. The draft expects systems that hold GMP data to log every manual user interaction automatically: who (and in which role), what (old and new value), when, and why, with the system prompting for the reason. The audit trail should be on and locked at all times, and nobody should be able to edit it.
Annex 11 draft §12.5 to 12.8
Audit trail review needs a written procedure
Reviews should follow a documented procedure saying who reviews what and when, be done by someone not involved in the activity, be targeted on risk rather than reading every entry, and happen in good time. A key element is checking the reason given for each change.
Annex 11 draft §15.7, §15.13, §15.19, §16.3, §16.4, §16.6
Security and backup become explicit requirements
The draft lists security controls the 2011 text never mentioned: timely patching, firewall reviews, regular penetration testing of critical internet-facing systems, and a tested disaster recovery plan with a recovery time objective. Backups should be physically and logically separate from the original data, and restores should be tested and documented.
Buying a cloud system
Buying a cloud monitoring system under the draft
Most temperature monitoring is now bought as a hosted service. The draft Annex 11 is specific about what you should check before you rely on one, and what the contract should say. The questions further down this page turn those clauses into things you can ask a supplier.
Annex 11 draft §7.2
Audit or assess the supplier before you rely on it
According to risk and how critical the system is, the draft expects an audit or a thorough assessment of the supplier's procedures and documentation, and of whether you can use their work instead of repeating it.
Annex 11 draft §7.5 (i) to (ix)
The contract has a nine-point checklist
The draft lists what a contract with a service provider should cover: activities and documents, procedures and regulatory requirements, reporting with SLAs and KPIs, supplier audits, support at inspections, resolution of issues, communication of quality and security issues, an exit strategy that keeps you in control of your data, and how new versions are released, including your chance to test them first.
Annex 11 draft §7.3, §14.2 (vii) and (viii)
Oversight runs on agreed SLAs and KPIs
Signing the contract is not the end of it. The draft expects you to oversee the provider's operation of the system against service levels and indicators agreed with them, and periodic reviews should look at those contracts and KPIs.
Annex 11 draft §6.1, §6.3
The supplier's requirements become your document
For SaaS the vendor may supply the requirements specification, but you should review it, decide whether the system fits your processes as it is, then take ownership of it and approve and control it for the version you use.
Annex 11 draft §7.4, §12.9
You must be able to explain it on inspection day
The documents behind the supplier's work should be accessible and explainable from your own site, with the supplier's help if needed. You should also be able to get a complete electronic copy of your data and audit trail; flat, locked files are not acceptable because the data must stay searchable and sortable.
Chapter 4 draft
Chapter 4: data governance, the data lifecycle and hybrid records
The revised Chapter 4 was written alongside the Annex 11 draft. It keeps the familiar rules on specifications, instructions and records, and adds new parts on data governance, risk management, signatures, data integrity and hybrid systems.
Chapter 4 draft §4.10 to 4.13, §4.21
A data governance system becomes an explicit expectation
Whether records are on paper, electronic or both, the draft expects a documented data governance system as part of the quality system. It should be based on risk, reviewed regularly, and decide the strength of controls from how critical the data is and how easily it could be altered without being noticed.
Chapter 4 draft §4.12, §4.15
Controls must cover the whole data lifecycle
The draft defines the lifecycle as creating and recording data, processing it, checking it, making decisions on it, retaining and retrieving it, and finally retiring or destroying it in a controlled way. Data ownership should be clear at every stage.
Chapter 4 draft §4.18, §4.76
Hosted records: you approve the provider's controls
If you rely on a hosted service to keep records, it is your job to understand, approve and justify the provider's controls under a service level agreement, including backup, restore and archiving. You should also review the provider's data management policies periodically.
Chapter 4 draft §4.63, Table 1; Annex 11 draft §2.4
ALCOA+ gains a tenth letter: Traceable
The Chapter 4 draft sets out data integrity principles as ALCOA++: attributable, legible, contemporaneous, original, accurate, complete, consistent, enduring, available and traceable. The Annex 11 draft still says ALCOA+, so expect that wording to be aligned in the final texts.
Chapter 4 draft §4.70, §4.82 to 4.85
Hybrid systems get their own section
A hybrid system is a mix of paper and electronic means, such as an electronic record that is printed and signed by hand. The draft expects each part to be defined and validated, a full description of the system, controls on the paper-to-electronic interface, and a procedure for reviewing and archiving both. It says electronic records should be signed electronically and hybrid signing should be avoided.
Chapter 4 draft §4.26, §4.63 (Original)
Printing out electronic data is not a safe default
Data recorded or processed electronically should not be converted to or kept on paper unless the hybrid rules are met or the conversion is validated or verified. Records captured in a dynamic state, which you can search and trend, should remain available in that state.
Annex 22 draft
Annex 22: artificial intelligence in GMP
Annex 22 is a new annex that adds to Annex 11 for systems with AI models embedded. The draft is narrow on purpose, and since the consultation its scope has been under active review.
Annex 22 draft §1
It covers machine learning in critical GMP uses
The draft applies where AI models are used in critical applications with a direct impact on patient safety, product quality or data integrity, for example to predict or classify data. It covers machine learning models that learned their behaviour from training data rather than being explicitly programmed.
Annex 22 draft §1
Only static, deterministic models for critical work
The draft covers static (frozen) models that give identical outputs for identical inputs. Dynamic models that keep learning in use, and models with probabilistic output, are outside its scope and the draft says they should not be used in critical GMP applications.
Annex 22 draft §1
Generative AI: not for critical uses, human in the loop elsewhere
The draft does not apply to generative AI and large language models and says they should not be used in critical GMP applications. In non-critical applications, qualified and trained people should always be responsible for checking the output is fit for its use: a human in the loop.
Annex 22 draft §5, §6
Test data must be representative and kept apart
Test data should cover the full range of intended inputs, including rare cases, be large enough for statistical confidence, and be correctly labelled. It must not have been used in training; people who have seen the test data should not train the same model, and generating test data with generative AI is not recommended.
Annex 22 draft §8, §9, §10
Models must show their working and their confidence
During testing, systems should record which features drove a decision, for example with SHAP, LIME or heat maps, and log a confidence score for each prediction. Low-confidence results may need to be flagged as undecided. In use, the model sits under change and configuration control, with its performance and input drift monitored.
EMA workshop report, Introduction and Next steps
The generative AI exclusion may be loosened
EMA reports that consultation comments supported allowing generative AI and LLMs in GMP, and the drafting group has discussed widening the scope where a fully documented, risk-based control strategy is in place. An expert workshop was held on 30 June and 1 July 2026; its report, published 2 October 2026, records no decision yet.
UK and Ireland
What it means in the UK and Ireland
The drafts are EU and PIC/S texts written for GMP. How they reach a site in Great Britain or Ireland depends on the law there, and for distributors on GDP rather than GMP.
PIC/S notice, 7 July 2025
A joint EU and PIC/S text
PIC/S announced the consultation on the same day as the Commission and describes the three documents as revisions to both the PIC/S and EU GMP Guides. The MHRA and the HPRA are both PIC/S participating authorities.
Human Medicines Regulations 2012, reg. C17(1) to (5)
Great Britain applies EU GMP as it stood at end 2020
Under regulation C17 of the Human Medicines Regulations 2012, EU GMP guidelines as they applied immediately before 31 December 2020 continue to apply unless the MHRA publishes replacements, after consultation. On our reading, a text the Commission adopts later does not apply in Great Britain automatically.
MHRA Guidance Note 5, §5.1 and §5.3
No MHRA statement on the drafts yet
We found no MHRA statement on whether it will adopt the revised Annex 11, Chapter 4 or Annex 22. Its manufacturer's licence guidance still points to EU GMP and the 2022 Orange Guide.
MHRA Guidance Note 5: Notes for applicants and holders of a Manufacturer's Licence
Annex 11 (2011), legal basis
Ireland gets the EU text once it is adopted
Ireland applies EU GMP directly. The Commission publishes these guidelines under Article 47 of Directive 2001/83/EC, so the adopted versions will apply to Irish manufacturers, with the HPRA as the inspecting authority. Until then, the 2011 texts stand.
EudraLex Volume 4, Annex 11: Computerised Systems (revision 1, in operation from 30 June 2011)
EU GDP 2013/C 343/01 §3.3.1; HPRA IA-G0046-8; Chapter 4 draft glossary
Distributors: GDP points to Annex 11
EU GDP section 3.3.1 requires computerised systems to be validated or verified before use, and the HPRA's GDP guide (April 2025) refers wholesalers to Annex 11 for further information. The Chapter 4 draft counts a wholesaler as a regulated user only if it also holds a manufacturing licence, so it is sensible to treat the draft Annex 11 as the benchmark for a monitoring system.
HPRA Guide to Good Distribution Practice of Medicinal Products for Human Use, IA-G0046-8
Buying cloud monitoring
Questions to ask your SaaS supplier
Under the draft, you stay accountable for a system someone else runs. These questions, drawn from the draft, show whether the supplier can support you.
- Can we audit you, on site or remotely, and what quality system, validation and security documents will you share before we sign? (draft Annex 11 §7.2)
- Will the contract cover all nine points the draft lists, including support at inspections and an exit strategy? (§7.5)
- What service levels and KPIs do you commit to, such as availability, incident response and resolution times, and how will you report them to us? (§7.3, §7.5 iii)
- Can you supply a requirements specification and validation package for the exact version we will run, for us to review and approve? (§6.3, §9.9)
- How much notice do we get of a new release, what changes in it, and can we test it before it reaches our account? (§7.5 ix)
- Does every alarm acknowledgement record the user, their role, the time and a comment, in a log no one can edit or switch off? (§8.4, §8.5)
- Does every login use a unique personal account, with MFA, lock-out after failed attempts and an inactivity logout users cannot change? (§11.1, §11.6 to 11.8)
- Does the audit trail record who, what, when and why for every manual change, with the old and new values, and is it always on and locked? (§12.1 to 12.3)
- Can we search, sort and export the audit trail, alarm log and access log ourselves, to support our own reviews? (§8.6, §11.9, §12.4)
- How often are backups taken, where are they kept, are they physically and logically separate, and when were restores last tested? (§16.2 to 16.6)
- Do you penetration test the service regularly, how quickly do you apply critical patches, and what is your recovery time objective? (§15.7, §15.13, §15.19)
- If we leave, can we take a complete electronic copy of our records and audit trail in a searchable format, and when is the rest deleted? (§7.5 viii, §12.9)
What to do now
Plan, don't panic. Assess the risk.
- Remember these are drafts. The 2011 Annex 11 and Chapter 4 are the texts you are inspected against today, and the final wording may change.
- Plan, don't panic. EMA's inspectors' working group aimed to give the Commission final Annex 11 and Chapter 4 texts in Q1 2026, and that date has passed with no adopted text, so watch the EudraLex page rather than guessing a date.
- Start from risk. Every part of the drafts scales with the risk to product quality, patient safety and data integrity, so update the risk assessment for each computerised system before anything else.
- Run a gap assessment of your monitoring system against the draft Annex 11, clause by clause, and note which gaps belong to you and which belong to your supplier.
- Review supplier agreements against the nine points in draft §7.5, and add the missing ones at the next renewal.
- Write, or tighten, a procedure for reviewing audit trails and alarm logs: who reviews, what they look at, how often, and what they do with what they find.
- Don't rewrite every SOP yet. Change procedures once the final texts are published, apart from gaps that are already weak under the 2011 rules.
How we're preparing
JTF installs and supports the Sematics monitoring platform in the UK. Sematics validates the platform under a validation lifecycle aligned to the 2011 Annex 11, the text in force today, and its validation programme also maps to the July 2025 draft clause by clause, designing to the draft wherever it asks for more: alarm logs, access controls, audit trail content and customer agreements, for example. The platform uses no machine learning in any GxP function, so draft Annex 22 does not apply to it. We do not claim compliance with any of these drafts, because they have not been adopted. When the final texts are published, the mapping will be checked against the adopted wording.
Questions
Common questions
Is the new Annex 11 in force?
No. It was published for consultation on 7 July 2025 and the consultation closed on 7 October 2025. On 18 October 2026 the European Commission still lists the January 2011 Annex 11 as current, and no adoption date or date of application has been published.
Does it apply in the UK?
Not automatically. In Great Britain, regulation C17 of the Human Medicines Regulations 2012 keeps EU GMP guidelines as they stood at the end of 2020 unless the MHRA publishes replacements after consultation, and we found no MHRA statement on these drafts. The MHRA is a PIC/S participating authority and PIC/S co-wrote the drafts, so they are a good guide to inspectors' thinking. Northern Ireland has separate arrangements that this page does not cover.
We are a wholesaler, not a manufacturer. Does this affect us?
Indirectly. The drafts are GMP texts, but EU GDP requires validated computerised systems, and the HPRA's GDP guide points wholesalers to Annex 11 for detail. If you use a monitoring system to prove storage conditions, the draft Annex 11 is the clearest statement of what a good one looks like.
Does Annex 22 ban AI?
No. The draft sets rules for static, deterministic machine learning models in critical GMP uses. It says dynamic, probabilistic and generative AI models should not be used in critical applications, and allows generative AI in non-critical ones with a qualified person checking the output. EMA is now reviewing whether to widen that scope.
What changes for SaaS and cloud systems?
The draft makes the regulated user's position explicit: you stay fully responsible, you should audit or assess the provider based on risk, oversee them through agreed SLAs and KPIs, own and approve the requirements and validation documents for the version you use, and have a contract covering nine set points, including an exit strategy.
What is a hybrid record under the Chapter 4 draft?
A record made up of paper and electronic parts, such as an electronic temperature report printed and signed by hand. The draft expects each part to be validated and controlled, the whole system described, and review and archiving procedures for both. It says electronic records should be signed electronically and hybrid systems avoided.
When will the final texts be published?
No date has been announced. EMA's inspectors' working group aimed to give the Commission final Annex 11 and Chapter 4 texts in Q1 2026, and that has not visibly happened. For Annex 22, a June 2026 EMA network meeting record pointed to publication in early 2027. Treat both as plans, not dates.
Sources
- Stakeholders' Consultation on EudraLex Volume 4, Good Manufacturing Practice Guidelines: Chapter 4, Annex 11 and New Annex 22, European Commission, 7 July 2025
- EudraLex Volume 4: Good Manufacturing Practice guidelines, European Commission, 18 October 2026
- Annex 11: Computerised Systems (consultation draft), European Commission, 7 July 2025
- Chapter 4: Documentation (consultation draft), European Commission, 7 July 2025
- Annex 22: Artificial Intelligence (consultation draft), European Commission, 7 July 2025
- EudraLex Volume 4, Annex 11: Computerised Systems (revision 1, in operation from 30 June 2011), European Commission, January 2011
- Joint stakeholders consultation on the revision of Chapter 4 on Documentation, Annex 11 on Computerised Systems and the new Annex 22 on Artificial Intelligence, PIC/S, 7 July 2025
- PIC/S participating authorities, PIC/S, 18 October 2026
- Good manufacturing practice: multistakeholder workshop on expert contributions to artificial intelligence guidance development (Annex 22), European Medicines Agency, 30 June 2026
- Report: GMP multistakeholder workshop on expert contributions to artificial intelligence guidance development (Annex 22), EMA/156789/2026, European Medicines Agency, 2 October 2026
- The 3-year work plan for the GMDP Inspectors Working Group, 2025 to 2027 (EMA/INS/GMP/50356/2025), European Medicines Agency, March 2025
- Minutes of the HMA/EMA joint Network Data Steering Group meeting, 16 June 2026 (EMA/143308/2026), European Medicines Agency, 22 June 2026
- The Human Medicines Regulations 2012, regulation C17: Guidelines on good manufacturing practice and good distribution practice, legislation.gov.uk, 18 October 2026
- MHRA Guidance Note 5: Notes for applicants and holders of a Manufacturer's Licence, MHRA, 2023
- Good manufacturing practice and good distribution practice, MHRA, 13 May 2024
- HPRA Guide to Good Distribution Practice of Medicinal Products for Human Use, IA-G0046-8, HPRA, 8 April 2025
- Guidelines of 5 November 2013 on Good Distribution Practice of medicinal products for human use (2013/C 343/01), European Commission, 23 November 2013
20-minute compliance check
Is your monitoring ready for the new Annex 11?
In 20 minutes we look at your monitoring system, supplier agreement and audit trail review against the draft, and where the gaps are. No product tour.