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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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.
Keywords: Microbiological, non-sterile, microbial attributes, pharmacopoeia
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ICH guideline Q4B Annex 4C on evaluation and recommendation of pharmacopoeial texts for use in the ICH regions on acceptance criteria for pharmaceutical preparations and substances for pharmaceutical use - Step 5 (PDF/192.35 KB)
Adopted
First published: 01/06/2009
Last updated: 13/07/2017
Legal effective date: 01/06/2009
EMEA/CHMP/ICH/308867/2008 -
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ICH: Q 4 B Annex 4C: To note for evaluation and recommendation of pharmacopoeial texts for use in the ICH regions on microbiological examination of non-sterile products: Acceptance criteria for pharmaceutical preparatio... (PDF/51.1 KB)
Draft: consultation closed
First published: 01/06/2008
Last updated: 01/06/2008
EMEA/CHMP/ICH/308867/2008