GMP Regulations in Transition: What You Need to Know
New Requirements for Documentation, Validation, and AI Systems
With the new drafts of Chapter 4, Annex 11, and the newly published Annex 22 on Artificial Intelligence, the GMP world is facing a significant update. The documents are currently open for public consultation – until October 7, 2025, companies, professional associations, and individuals have the opportunity to submit feedback.
The drafts bring far-reaching changes:
- Chapter 4 expands requirements for documentation, data lifecycle, and governance
- Annex 11 clarifies validation, audit trails, cloud usage, and cybersecurity
- Annex 22 defines regulatory requirements for AI systems in the GxP environment
In our webinar, Dr. Annabel Dischinger will explain which changes are particularly relevant, how they could affect existing processes, and how you can already position yourself strategically.
Event details:
- Date: Thursday, September 11, 2025
- Time: 11:00 a.m.
- Duration: approx. 30 minutes
Participation is free of charge. Secure your spot now via the contact form and receive your access details.
We look forward to seeing you – and to exploring together how you can proactively adapt to the new regulatory requirements in the GMP environment.
Note: Participation is reserved for Thescon customers and prospects. Service providers and consultants are excluded.