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

This 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.

Keywords: Microbiological, non-sterile, microbial enumeration tests, pharmacopoeia

Current effective version

ICH guideline Q4B Annex 4A on evaluation and recommendation of pharmacopoeial texts for use in the ICH regions on micro enumeration - Step 5

Adopted Reference Number: EMEA/CHMP/ICH/308671/2008 Legal effective date: 01/06/2009

Document history - First version (current)

ICH guideline Q4B Annex 4A on evaluation and recommendation of pharmacopoeial texts for use in the ICH regions on micro enumeration - Step 5

Adopted Reference Number: EMEA/CHMP/ICH/308671/2008 Legal effective date: 01/06/2009

ICH: Q 4 B Annex 4A: To note for evaluation and recommendation of pharmacopoeial texts for use in the ICH regions on microbiological examination of non-sterile products: Microbial enumeration tests general chapter - Ste...

Draft: consultation closed Reference Number: EMEA/CHMP/ICH/308671/2008