ICH Q4B Annex 4A Microbiological examination of non-sterile products: microbial enumeration tests

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Current effective version

Adopted guideline

Reference numberCHMP/ICH/308671/07
Published01/12/2008
Effective from01/06/2009
KeywordsMicrobiological, non-sterile, microbial enumeration tests, pharmacopoeia
DescriptionThis annex is the result of the Q4B process for Microbiological Examination of Non-Sterile Products: Microbial Enumeration Tests. The proposed texts were submitted by the Pharmacopoeial Discussion Group. It aims to facilitate the recognition of pharmacopoeial procedures for microbial enumeration tests by regulatory authorities in the ICH regions.


Document history

First version

Current version

Adopted guideline


Draft guideline

In operation: 01/06/2009–present


Published: 01/06/2008


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