Compare ICH Q10 and Annex 15

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ICH Q10Annex 15
AuthorityICHEuropean Commission
Legal weightGuidance & Q&AGMP guide & annexes
StatusFinalIn force
Last verifiedNot yetNot yet
Summary

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

The EU GMP annex on qualification and validation.

Lifecycle
  • 8 Apr 2009 Published by FDA as guidance
  • 1 Oct 2015 Came into operation
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.