1. Q7 good manufacturing practice guidance for active pharmaceutical ingredients: questions and answers Publication: Silver Spring, MD : Center for Drug Evaluation and Research, April 2018 Subject(s): Chemistry, Pharmaceutical -- standardsPharmaceutical Preparations -- standardsQuality ControlDrug ContaminationDrug Labeling -- standardsInternational CooperationHumansUnited StatesUnited States. Department of Health and Human Services.United States. Food and Drug Administration.