ICH Q4B Annex 8 Sterility test - Scientific guideline

This annex is the result of the Q4B process for the Sterility Test General Chapter. The proposed texts were submitted by the Pharmacopoeial Discussion Group. It aims to facilitate the recognition of pharmacopoeial sterility testing procedures by regulatory authorities in the ICH regions.

Keywords: Sterility test, pharmacopoeia

Current effective version

ICH guideline Q4B Annex 8 on evaluation and recommendation of pharmacopoeial texts for use in the ICH regions sterility test - general chapter - Step 5

Adopted Reference Number: EMA/CHMP/ICH/645592/2008 Legal effective date: 01/12/2009

Document history - First version (current)

ICH guideline Q4B Annex 8 on evaluation and recommendation of pharmacopoeial texts for use in the ICH regions sterility test - general chapter - Step 5

Adopted Reference Number: EMA/CHMP/ICH/645592/2008 Legal effective date: 01/12/2009

ICH: Q 4 B Annex 8: Annex 6 to note for evaluation and recommendation of pharmacopoeial texts for use in the ich regions on sterility test and general chapter - Step 3

Draft: consultation closed Reference Number: EMEA/CHMP/ICH/645592/2008