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

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Current effective version

Adopted guideline

Reference numberCHMP/ICH/308867/08
Effective from01/06/2009
KeywordsMicrobiological, non-sterile, microbial attributes, pharmacopoeia
DescriptionThis 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

Adopted guideline

Draft guideline

In operation: 01/06/2009–present

Published: 01/06/2008

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