第1页共96页 GuidanceforIndustry 行业指南 SterileDrugProducts ProducedbyAsepticProcessing— CurrentGoodManufacturingPractice 无菌工艺生产的无菌药品-药品生产 质量管理规范 U.S.DepartmentofHealthandHumanServices 美国卫生部 FoodandDrugAdministration 食品药品管理局 CenterforDrugEvaluationandResearch(CDER) 药物评价与研...
Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center for Biologics Evaluation and Research (CBER) Office of Regulatory Affairs (ORA) September 2004 Pharmaceutical CGMPs Guidance for Industry Sterile Drug Products Produced by Aseptic ...
翻译:杜晓頔 校对:谢皖、马志莹 第 5 页共 96 页 Guidance for Industry Sterile Drug Products Produced by Aseptic Processing — Current Good Manufacturing Practice 对于作为新药申请或简略药品申请(NDA or ANDA)或生物制剂许可申请(BLA), 在阅读本指南时应结合无菌药品生产指南的内容,指南的标题是关于递交人...
第1 页共 96 页 Guidance for Industry 行业指南 Sterile Drug Products Produced by Aseptic Processing — Current Good Manufacturing Practice 无菌工艺生产的无菌药品-药品生产质量管理规范 U.S. Department of Health and Human Services 美国卫生部 Food and Drug Administration 食品药品管理局 Center for Drug ...
FDA无菌加工生产的无菌药品指南中英文对照版
September2004 PharmaceuticalCGMPs GuidanceforIndustry SterileDrugProducts ProducedbyAsepticProcessing— CurrentGoodManufacturingPractice Additionalcopiesareavailablefrom: OfficeofTrainingandCommunication DivisionofDrugInformation,HFD-240 CenterforDrugEvaluationandResearch ...
Translated from 译自: Guidance for Industry Sterile Drug Products Produced by Aseptic Processing Current Good Manufacturin
Copyright SCI Version 1 Translated from / 译自 Guidance for Industry Sterile Drug Products Produced by Aseptic Processing — Current Good Manufacturing Practice 行业指南 无菌加工生产的无菌药品 —现行的生产质量管理规范(cGMP U.S. Department of Health and Human Services Food and Drug Administration Center...
内容提示: Copyright SCI Version 1 Translated from / 译自 Guidance for Industry Sterile Drug Products Produced by Aseptic Processing — Current Good Manufacturing Practice 行业指南 无菌加工生产的无菌药品 —现行的生产质量管理规范(cGMP U.S. Department of Health and Human Services Food and Drug ...
FDA无菌生产指南 中英文对照版.doc,Translated from / 译自: Guidance for Industry Sterile Drug Products Produced by Aseptic Processing — Current Good Manufacturing Practice 行业指南 无菌加工生产的无菌药品 —现行的生产质量管理规范(cGMP) U.S. Department of