ICH Q4B Annex 8 Sterility test

Current effective version

PDF iconAdopted guideline

Reference number CHMP/ICH/645592/08
Published 01/06/2009
Effective from 01/12/2009
Keywords Sterility test, pharmacopoeia

This annex is the result of the Q4B process for the Sterility Test General Chapter. The proposed texts were submitted by the Pharmacopoeial Discussion Group. It aims to facilitate the recognition of pharmacopoeial sterility testing procedures by regulatory authorities in the ICH regions.

Document history

First version

Current version

PDF iconAdopted guideline


PDF iconDraft guideline

In operation: 01/12/2009–present


Published: 01/12/2008

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