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ICH Q10Chapter 1 revision
AuthorityICHEuropean Commission
Legal weightGuidance & Q&AGMP guide & annexes
StatusFinalDraft
Last verifiedNot yetNot yet
Summary

ICH model for an effective quality management system for the pharmaceutical industry.

Draft revision of the EU GMP quality system chapter, recommended jointly by the GMP/GDP Inspectors Working Group and the PIC/S Committee to reflect ICH Q9(R1). Draft only.

Lifecycle
  • 8 Apr 2009 Published by FDA as guidance
  • 3 Sep 2025 Consultation document published
SourceOfficial text
Source: ICH.
Official text
Source: European Commission. Licensed under CC BY 4.0.

These facts are placed side by side from each record. This page does not say which is stricter or whether requirements differ. Read the official texts.