There is a stakeholder's consultation on revisions to Good Manufacturing Practice Guidelines: Chapter 4 (Documentation), Annex 11 (Computerised Systems) and New Annex 22 (Artificial Intelligence). Deadline for comments is 07 October 2025.
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- Jan 27, 2025
The final version of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) Guideline for Good Clinical Practice (GCP) E6(R3) was adopted on 06 January 2025. The guideline has been restructured from the previous version E6 (R2). E6(R3) Section 4 (Data Governance - Investigator and Sponsor) now includes data governance, data lifecycle, and computerised systems.
- Dec 27, 2024
It was great to see everyone at the GAMP CoP UK Forum, 19-Nov-2024 in Stevenage. Topics included an Interactive Session - Slipping through the gaps: How do defects escape into the wild?, Disaster Recovery - Cybersecurity, Data Lakes & Analytics, a panel discussion on AI - Do You Know Where It is Being Used and What For?, Transforming Patient Engagement with Critical Medical Information, and a Good Practice Guide Update including alignment with GAMP 5, 2nd Edition.
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