11. Q4B evaluation and recommendation of pharmacopoeial texts for use in the ICH regions: annex 8 (R1) : sterility test general chapter Publication: Silver Spring, MD : Center for Drug Evaluation and Research, September 2017 Subject(s): Chemistry, Pharmaceutical -- standardsDrug ApprovalPharmacopoeias as Topic -- standardsSterilizationCongresses as TopicInternational CooperationHumansEuropeJapanUnited StatesUnited States. Department of Health and Human Services.United States. Food and Drug Administration.
