This guidance compliments the Submission Guidance by describing procedures and practices that will help enable a sterile drug manufacturing facility to meet CGMP requirements relating, for example, to facility design, equipment suitability, process validation, and quality control. 作为新药申请(NDA)、简化...
This guidance pertains to current good manufacturing practice (CGMP) regulations (21 CFR parts 210 and 211) when manufacturing sterile drug and biological products using aseptic processing. Although the focus of this guidance is on CGMPs in 21 CFR 210 and 211, ...
内容提示: Translated from / 译自:Guidance for IndustrySterile Drug Productsg 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标准(cGMP〕U.S. Department of Health and Human ServicesFood and Drug AdministrationCenter for Drug Evaluation ...
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...
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 for Drug Evaluation ...
内容提示: Guidance for Industry 工业界指南 Sterile Drug Products Produced by Aseptic Processing — Current Good Manufacturing Practice 无菌工艺生产的灭菌药品 CGMP U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center for ...
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...
FDA无菌加工生产的无菌药品指南中英文对照版
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...
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