1. Q4B evaluation and recommendation of pharmacopoeial texts for use in the ICH regions: annex 3(R1) : test for particulate contamination : subvisible particles general chapter Publication: Silver Spring, MD : Center for Drug Evaluation and Research, September 2017 Subject(s): Drug ApprovalDrug ContaminationParticulate MatterPharmacopoeias as Topic -- standardsCongresses as TopicInternational CooperationHumansEuropeJapanUnited StatesUnited States. Department of Health and Human Services.United States. Food and Drug Administration.