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

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Current effective version

Adopted guideline

Reference numberCHMP/ICH/308817/07
Published01/06/2009
Effective from01/12/2008
KeywordsMicrobiological, non-sterile,  tests for specified micro-organisms, pharmacopoeia
DescriptionThis 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

Adopted guideline


Draft guideline

In operation: 01/12/2008–present


Published: 01/06/2008


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