Because a phase 1 clinical trial initially introduces an investigational new drug into human subjects, appropriate CGMP help ensure subject safety. This guidance applies, as part of CGMP, quality control (QC) principles to the...
Because a phase 1 clinical trial initially introduces an investigational new drug into human subjects, appropriate CGMP help ensure subject safety. This guidance applies, as part of CGMP, quality control (QC) principles to the manufacture of phase 1 investigational drugs (i.e., interpreting and im...
Guidance for Industry Sterile Drug Products Produced by Aseptic Processing — Current Good Manufacturing Practice This guidance represents the Food and Drug Administration's (FDA's) current thinking on this topic. It does not create or confer any rights for or on any person and does not operate ...
This guidance is intended to help manufacturers meet the requirements in the Agency's current good manufacturing practice (CGMP) regulations (2l CFR parts 210 and 211) when manufacturing sterile drug and biological products using aseptic processing. This guidance rep...
FDA无菌加工生产的无菌药品指南中英文对照版
药品指南fda加工drugcber GuidanceforIndustry SterileDrugProducts ProducedbyAsepticProcessing— CurrentGoodManufacturing 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.DepartmentofHealthandHumanServices FoodandDrugAdministration CenterforDrugEvaluationandResearch(CDER) CenterforBiologicsEva...
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...
Translated from 译自: Guidance for Industry Sterile Drug Products Produced by Aseptic Processing Current Good Manufacturin
翻译:杜晓頔 校对:谢皖、马志莹 第 7 页共 96 页 Guidance for Industry Sterile Drug Products Produced by Aseptic Processing — Current Good Manufacturing Practice 品的各部分无菌之前,最终产品的各个部分都要进行灭菌。例如,玻璃容器要经 过干热灭菌,胶塞要经过湿热灭菌,液体药品要经过除菌过滤。以上每一个...
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 ...