ICH Q4B Annex 8 Sterility test

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Current effective version

Adopted guideline

Reference numberCHMP/ICH/645592/08
Effective from01/12/2009
KeywordsSterility 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

Adopted guideline

Draft guideline

In operation: 01/12/2009–present

Published: 01/12/2008

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