ICH Q4B Annex 4B Test for microbiological examination of non-sterile products: tests for specified microorganisms

Current effective version

PDF iconAdopted guideline

Reference number CHMP/ICH/308817/07
Published 01/06/2009
Effective from 01/12/2008
Keywords Microbiological, non-sterile, tests for specified micro-organisms, pharmacopoeia
Description This annex is the result of the Q4B process for Microbiological Examination of Non-Sterile Products: Tests for Specified Micro-organisms. The proposed texts were submitted by the Pharmacopoeial Discussion Group. It aims to facilitate the recognition of pharmacopoeial procedures for microbiological examination of non-strile products by regulatory authorities in the ICH regions.

Document history

First version

Current version

PDF iconAdopted guideline


PDF iconDraft guideline

In operation: 01/12/2008–present


Published: 01/06/2008

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