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

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Current effective version

Adopted guideline

Reference numberCHMP/ICH/561176/2007
Published01/06/2008
Effective from01/12/2008
KeywordsParticulate contamination: sub-visible particles, insoluble particulate matter test for injections, pharmacopoeia
DescriptionThis 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.


Document history

First version

Current version

Adopted guideline


Draft guideline

In operation: 01/12/2008–present


Published: 01/11/2007


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