Compare Chapter 1 revision and Chapter 1 (2013)

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Chapter 1 revisionChapter 1 (2013)
AuthorityEuropean CommissionEuropean Commission
Legal weightGMP guide & annexesGMP guide & annexes
StatusDraftIn force
Last verifiedNot yetNot yet
Summary

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.

The current EU GMP chapter on the pharmaceutical quality system.

Lifecycle
  • 3 Sep 2025 Consultation document published
  • 31 Jan 2013 Came into operation
SourceOfficial text
Source: European Commission. Licensed under CC BY 4.0.
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.