The United States Pharmacopeia (USP) has released a draft of Chapter <1029> titled “Good Documentation Guidelines and Data Integrity” for public comment in the USP Pharmacopeial Forum as of early July 2025. The draft revises the 2018 version and incorporates expanded guidance on documentation practices and data integrity.
Stakeholders can submit comments until 30 September 2025 after registering on the Pharmacopeial Forum website – link.
On 7 July 2025, the European Commission released draft revisions to EU GMP Chapter 4 (Documentation), Annex 11 (Computerised Systems), and the new Annex 22 (Artificial Intelligence) for public consultation. These updates aim to align GMP standards with advances in digital systems, AI, and documentation practices.
🔍 Who Should Participate
Public health stakeholders, including GMP manufacturers, importers, and quality professionals, should review and contribute feedback.
📢 How to Submit Feedback
Stakeholder organizations should gather comments from members, compile them, and submit through the EU Survey tool.
🗓 Consultation Period
Start: 7 July 2025
Deadline: 7 October 2025, 23:59 (CEST)
🔗 Link: Click Here
