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

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


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