EC: Revised Chapter 1 of the EU GMP Guide Published
Today, the European Commission published the revised Chapter 1, Pharmaceutical Quality System, of the EU GMP Guide. The public consultation phase closes on December 3, 2025.
Chapter 1 is revised to align with ICH Q9(R1), strengthening knowledge and risk management across the product lifecycle.
It embeds risk-based decisions to improve consistent quality and supply, with early identification of manufacturing risks to prevent shortages.
The update also clarifies Product Quality Review (PQR) expectations, including product grouping and reviews when only a few batches were made.
Source:
EC: Stakeholders’ Consultation on EudraLex Volume 4 - Good Manufacturing Practice Guidelines: Chapter 1
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