EU GMP Chapter 4 revision: Documentation (draft)

European Commission · Draft

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Unverified: the editor has not yet checked this record against the official source.

Summary

Revised GMP documentation chapter, consulted on jointly with PIC/S. It updates expectations for records in any format, data governance and the documentation lifecycle, aligning with the revised Annex 11. Draft only.

Dated events

1. Target 31 Dec 2026 Target: final text to European Commission (Q4 2026) Source for Target: final text to European Commission (Q4 2026)
2. 7 Oct 2025 Public consultation closed Source for Public consultation closed
3. 7 Jul 2025 Draft published for public consultation Source for Draft published for public consultation

Official source

Official text

Source: European Commission. Licensed under CC BY 4.0.