Revised EU- PIC/S GMP on Documentation, Computer Systems and AI
- Date
- July 21, 2025
- Category
EU Regulations
- Description
On 7 July 2025 the EU and PIC/S jointly published draft revisions to the following sections of their GMP guides:
- Chapter 4, Documentation
- Annex 11, Computer Systems
- Annex 22, a new annex on Artificial Intelligence.
Comments on these proposed changes should be submitted by 7 October 2025.
The changes are being proposed in light of the rapid advancement of digital technologies and the implementation of AI systems in pharmaceutical manufacturing, to ensure that the GMP guidelines continue to provide clear, practical and relevant guidance for manufacturers and national competent authorities. The specific changes to the three sections of the GMP Guide are as follows:
Chapter 4 – Documentation
The chapter has been restructured and significantly expanded. The revised chapter has a focus on data integrity throughout and the new structure is as follows:
- 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 11 – Computer Systems
This annex has also been restructured and significantly expanded, going from 5 pages to 19. The new structure has the following subject headings:
- 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.