1. Q4B evaluation and recommendation of pharmacopoeial texts for use in the ICH regions: annex 4B(R1) : microbiological examination of nonsterile products : tests for specified microorganisms general chapter Publication: Silver Spring, MD : Center for Drug Evaluation and Research, September 2017 Subject(s): Drug ApprovalMicrobiological Techniques -- standardsPharmacopoeias as Topic -- standardsCongresses as TopicInternational CooperationHumansEuropeJapanUnited StatesUnited States. Department of Health and Human Services.United States. Food and Drug Administration.