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

Current effective version

PDF icon<b>Adopted guideline</b>

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

PDF iconAdopted guideline


PDF iconDraft guideline

In operation: 01/06/2009–present


Published: 01/06/2008


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