ICH 4 QB Annex 9 Tablet friability - Scientific guideline

This annex is the result of the Q4B process for the Tablet Fragibility General Chapter. The proposed texts were submitted by the Pharmacopoeial Discussion Group. It aims to facilitate the recognition by regulatory authorities of pharmacopoeial analytical procedures and acceptance criteria relating to tablet friability for use in the ICH regions.

Keywords: Tablet friability, pharmacopoeia

Current effective version

ICH guideline Q4B Annex 9 on evaluation and recommendation of pharmacopoeial texts for use in the ICH regions on tablet friability - general chapter - Step 5

Adopted Reference Number: EMEA/CHMP/ICH/379801/2009 Legal effective date: 01/05/2010

Document history - First version (current)

ICH guideline Q4B Annex 9 on evaluation and recommendation of pharmacopoeial texts for use in the ICH regions on tablet friability - general chapter - Step 5

Adopted Reference Number: EMEA/CHMP/ICH/379801/2009 Legal effective date: 01/05/2010

ICH: Q 4 B Annex 9: Tablet friability general chapter - Step 3

Draft: consultation closed Reference Number: EMEA/CHMP/ICH/379801/2009