Drafts of EU GMP Guideline Annex 11, Annex 22 and Chapter 4 released for comment

On 16 November 2022, the EU Commission published a concept paper on the planned revision of EU GMP Guide Annex 11 “Computerised Systems”. Long awaited, the drafts for Annex 11 “Computerised Systems” and the newly added Annex 22 “Artificial Intelligence” were published on 7 July 2025, together with the revised version of Chapter 4 “Documentation” of the EU GMP Guide.

Comments on the three drafts can be submitted until 7 October 2025. Comments can be submitted via “stakeholder organisations” or, if you are not a member of a “stakeholder organisation”, specifically on the respective draft via the EU survey tool.

• Revision of Chapter 4
• Revision of Annex 11
• New Annex 22

Initial overview

In general, it can be said that the drafts for Annex 11 and Chapter 4 have been restructured and have also increased significantly in scope. The draft Annex 11 has grown from 5 to 19 pages and the draft Chapter 4 from the original 9 pages to 17 pages. Approximately 2 pages of this are attributable to an attached glossary.

Annex 11 Draft

Annex 11 consists if 17 chapters plus a glossary

• Scope
• Principles
• Pharmaceutical Quality System
• Risk Management
• Personnel and Training
• System Requirements
• Supplier and Service Management
• Alarms
• Qualification and Validation
• Handling of Data
• Identity and Access Management
• Audit Trails
• Electronic Signatures
• Periodic Review
• Security
• Backup
• Archiving
• Glossary

In addition to the restructuring, the weighting of the topics has also changed significantly. The top 5 topics in the Annex 11 draft, in order of scope, are:

• Security
• Identity and Access Management
• Qualification and Validation
• Audit Trails
• Supplier and Sevice Management

While “Validation” is by far the most comprehensive topic in the current Annex 11, the new draft shows a clear shift towards the topics of “Security”, “Identity and Access Management” and “Audit Trail”.

Chapter 4 Draft

The draft of Chapter 4 has also been significantly expanded and restructured. In particular, the long-established principles of data integrity have been added. The draft of Chapter 4 now consists of the following topics:

• Principle
• Data governance systems
• Risk management
• General requirements for documentation
• Master Documents
• Generation and Control of Documentation
• Good documentation practice
• Signatures in GMP relevant documentation
• Retention of documents
• Data Integrity in documentation
• Hybrid Systems
• Glossary

Annex 22 Draft

In contrast to the drafts of Annex 11 and Chapter 4, the draft of Annex 22 has remained pleasingly short and consists of the following chapters:

• Scope
• Principles
• Intended Use
• Acceptance Criteria
• Test Data
• Test Data Independency
• Test Execution
• Explainability
• Confidence
• Operation
• Glossary

Summary

As with Annex 1, the specifications have been significantly expanded and detailed. Opinions may differ as to whether this is sensible. In any case, it is positive that current issues have been addressed and implemented. The comments certainly provide an opportunity to influence the final versions of the documents. More detailed analyses of the drafts will be published in the newsletter in the coming weeks.