ICH Q4B Annex 3 Test for particulate contamination: sub-visible particles - Scientific guideline

This annex is the result of the Q4B process for Test for Particulate Contamination: Sub-Visible Particles. The proposed texts were submitted by the Pharmacopoeial Discussion Group. It aims to facilitate the recognition of pharmacopoeial procedures for the test for sub-visible particulates contmination by regulatory authorities in the ICH regions. It describes special requirements for this test to be considered interchangable for use in the ICH regions.

Keywords: Particulate contamination: sub-visible particles, insoluble particulate matter test for injections, pharmacopoeia

Current effective version

ICH guideline Q4B Annex 3 on evaluation and recommendation of pharmacopoeial texts for use in the ICH regions on test for particulate contamination: sub-visible particles general chapter - Step 5

Adopted Reference Number: EMEA/CHMP/ICH/561176/2007 Legal effective date: 01/12/2008

Document history - First version (current)

ICH guideline Q4B Annex 3 on evaluation and recommendation of pharmacopoeial texts for use in the ICH regions on test for particulate contamination: sub-visible particles general chapter - Step 5

Adopted Reference Number: EMEA/CHMP/ICH/561176/2007 Legal effective date: 01/12/2008

ICH: Q 4 B Annex 3: To note for evaluation and recommendation of pharmacopoeial texts for use in the ich regions on test for particulate contamination: Sub-visible particles general chapter - Step 3

Draft: consultation closed Reference Number: EMEA/CHMP/ICH/561176/2007