EU Opens Consultation on Revised GMP Guidelines – Chapter 1

The European Commission has launched a stakeholder consultation on the revised Chapter 1 of EudraLex Volume 4 – GMP Guidelines, with comments due by 3 December 2025. The update, developed by the EMA GMDP Inspectors Working Group in collaboration with PIC/S, aims to strengthen science-based regulation and risk management.

Key revisions cover Quality Risk Management (QRM), Knowledge Management (KM), and Product Quality Review (PQR). Updates to QRM reflect the ICH Q9(R1) guideline, introducing seven new sections that highlight risk-based decision-making, scientific rationale, proactive risk identification, and prevention of supply chain vulnerabilities.

KM is reinforced as a core GMP element, aligned with ICH Q10, stressing its integration with QRM to create early warning systems and support continuous improvement.

For PQRs, new clarifications define requirements for limited or no batch production, mandate trending data inclusion, and allow flexible review timelines with proper justification.

05-09-2025