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 replaces the 1987Industry Guideline on...
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...
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 ...
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 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
SCHICHT, H., Regulatory Guidance for Manufacturing Sterile Pharmaceutical Products - Recent EC and FDA Developments, Bioprocessing and Biopartnering (Touchbriefings, London), (2006), 42-44.Schicht H (2006) Regulatory guidance for manufacturing sterile pharmaceutical products--recent E...
Thus,inestablishingthelevelofcontaminationallowedinahighpuritywatersystemusedinthemanufactureofanon-sterileproductrequiresanunderstandingoftheuseoftheproduct,theformulation(preservativesystem)andmanufacturingprocess.Forexample,antacids,whic 45、hdonothaveaneffectivepreservativesystem,requireanactionlimitbelowthe100CFU/mL...
this should not deter the inspection team from making an assessment of the firm's manufacturing process(es). Especially, for a bulk drug substance that has been manufacturedfor years employing an established process for many years and is not expectedto change, the firm should have had sufficient...
Quality characteristics must be assured through adherence to good manufacturing practices in the production, control, and testing of drug products intended for investigational as well as commercial use. A draft guideline on the preparati... JW Levchuk - 《Journal of Parenteral Science & Technology ...