正在整理PDA技术报告 目测TR有88个

cuix

正在整理PDA技术报告 目测TR有88个，还缺列表这些，哪位大神可以分享一下？

TR 30 2012	最终湿热灭菌的药物和医疗器械参数放行 Parametric Release of Pharmaceuticals and Medical Device Products Terminally Sterilized by Moist Heat
TR 39 Rev-2021	温度受控药物指南：通过运输环境来维护对温度敏感的药物的质量 Guidance for Temperature-Controlled Medicinal Products: Maintaining the Quality of Temperature-Sensitive Medicinal Products through the Transportation Environment
TR 41 Rev-2022	病毒过滤 Virus Filtration
TR 43 Rev-2013	药物生产用模型制备和管式玻璃容器的识别和分类 Identification and Classification of Nonconformities in Molded and Tubular Glass Containers for Pharmaceutical Manufacturing: Covering Ampoules, Bottles,Cartridges, Syringes and Vials
TR 46 2009	最终里程：给最终用户的药物优良销售规范指南 Last Mile: Guidance for Good Distribution Practices for Pharmaceutical Products to the End User
TR 50 2010	支原体测试替代性方法 Alternative Methods for Mycoplasma Testing
TR 53 2011	行业指南：支持新药销售的稳定性测试 Guidance for Industry: Stability Testing to Support Distribution of New Drug Products
TR 54-6 2019	赋形剂的正式风险评估 Formalized Risk Assessment for Excipients
TR 55 2012	药物和保健行业中2，4，6-三溴苯甲醚和2，4，6-三氯苯甲醚污染和气味的检测和移除 Detection and Mitigation of 2,4,6-Tribromoanisole and 2,4,6-Trichloroanisole Taints and Odors in the Pharmaceutical and Consumer Healthcare Industries
TR 57-2	生物技术产品的分析方法开发和鉴定 Analytical Method Development and Qualification for Biotechnology Products
TR 63 2013	临床试验临时制备药物的质量要求 Quality Requirements for the Extemporaneous Preparation of Clinical Trial Materials
TR 67 2014	非无菌药物、医疗器械和化妆品中致病菌排除 Exclusion of Objectionable Microorganisms from Nonsterile Pharmaceuticals,Medical Devices, and Cosmetics
TR 71 2015	病毒检测的新方法 Emerging Methods for Virus Detection
TR 72 2015	全球销售控温药品的防热保护系统 ：确认与操作指南 Passive Thermal Protection Systems for Global Distribution: Qualification and Operational Guidance

流火如夏

楼主有PDA TR081 的吗？

cuix

流火如夏 发表于 2022-8-4 13:14
楼主有PDA TR081 的吗？

younx

楼主能把有的分享一下吗

等待新一

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