ICH Q4B Annex 4C Test for microbiological examination of non-sterile products: acceptance criteria for pharmaceutical preparations and substances for pharmaceutical use

Current effective version

PDF iconAdopted guideline

Reference number CHMP/ICH/308867/08
Published 01/12/2008
Effective from 01/06/2009
Keywords Microbiological, non-sterile, microbial attributes, pharmacopoeia
Description This annex is the result of the Q4B process for Microbiological Examination of Non-Sterile Products: Acceptance Criteria for Pharmaceutical Preparations and Substances for Pharmaceutical Use. The proposed texts were submitted by the Pharmacopoeial Discussion Group. It aims to facilitate the recognition of pharmacopoeial procedures for microbiological examination of non-sterile products 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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