ICH Q4B Annex 4B Test for microbiological examination of non-sterile products: tests for specified microorganisms - Scientific guideline

This annex is the result of the Q4B process for Microbiological Examination of Non-Sterile Products: Tests for Specified Micro-organisms. The proposed texts were submitted by the Pharmacopoeial Discussion Group. It aims to facilitate the recognition of pharmacopoeial procedures for microbiological examination of non-strile products by regulatory authorities in the ICH regions.

Keywords: Microbiological, non-sterile, tests for specified micro-organisms, pharmacopoeia

Current effective version

ICH guideline Q4B Annex 4B on evaluation and recommendation of pharmacopoeial texts for use in the ICH regions on Tests for specified micro-organisms - Step 5

Adopted Reference Number: EMEA/CHMP/ICH/308817/2008 Legal effective date: 01/06/2009

Document history - First version (current)

ICH guideline Q4B Annex 4B on evaluation and recommendation of pharmacopoeial texts for use in the ICH regions on Tests for specified micro-organisms - Step 5

Adopted Reference Number: EMEA/CHMP/ICH/308817/2008 Legal effective date: 01/06/2009

ICH: Q 4 B Annex 4B: To note for evaluation and recommendation of pharmacopoeial texts for use in the ICH regions on microbiological examination of non-sterile products: Tests for specified micro-organisms - General chap...

Draft: consultation closed Reference Number: EMEA/CHMP/ICH/308817/2008