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

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

Current effective version

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

Adopted Reference Number: EMEA/CHMP/ICH/308867/2008 Legal effective date: 01/06/2009

Document history - First version (current)

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

Adopted Reference Number: EMEA/CHMP/ICH/308867/2008 Legal effective date: 01/06/2009

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...

Draft: consultation closed Reference Number: EMEA/CHMP/ICH/308867/2008