TR56 治疗用蛋白质药用物质研发中与阶段相适当的质量体系和CGMP应用 Application of Phase-Appropriate ...
类别 ISPE指南名称 Date GAMP GAMP Guide: Records & Data Integrity / 记录和数据完整性 2017 GAMP ...
类别 ISPE指南名称 Date GAMP GAMP Guide: Records & Data Integrity / 记录和数据完整性 2017 GAMP ...
PDA TR No. 56-治疗用蛋白质药用物质研发中与阶段相适当的质量体系和CGMP应用(API或生物活性成分)-2016(1).pdf,Technical Report No. 56 (Revised 2016) Application of Phase-Appropriate Quality System and cGMP to the Development of Therapeutic Protein Drug Subst
56. Application of Phase-Appropriate Quality Systems and CGMP to the Development of Therapeutic Protein Drug Substance 2012治疗用蛋白质药用物质研发中与阶段相适当的质量体系和CGMP应用,2012 57. Analytical Method Validation and Transfer for Biotechnology Products 2012生物制品的分析方法验证和转移,2012 ...
Exposure Phase 灭菌保温阶段 The phase of the sterilization cycle in which the appropriate parameters are maintained within defined ranges for the time (exposure time or dwell period) and temperature determined to be necessary to achieve the desired lethality. [Synonym: dwell period] 系指灭菌周期中,...
analyticalmethodsthatareappropriatetothelifecyclephaseoftheproduct. EngineeringBatch Thismayalsobereferredtoasanengineeringrun,demonstrationbatch,or demonstrationrun. 为示范生产工艺的转移并确认适用于产品生命周期阶段的已确认设备、控制和分 析方法的适配性而进行的生产运行。这也可以称为工程运行、示范批或示范运行。
During the commercial development phase, more detailed process knowledge should be collected that describes critical and noncritical parameters, operating ranges, and product impurity profiles as a function of each individual unit operation and the process as a whole (23).在商业开发阶段，应收集更详细...
PDA TR46 药品良好分销规范的最后一英里指南-2(英文).docx,Technical Report No. 46 Last Mile: Guidance for Good Distribution Practices for Pharmaceutical Products to the End User 2009 Last Mile: Guidance For Good Distribution Practices For Pharmaceutical P
PDA 技术报告No. 31 Technical Report No. 31 PDA 1. Objective 目的 The purpose of this article is to provide guidance to laboratory scientists, technicians and managers responsible for the implementation, testing, control and usage of Laboratory Data Acquisition Systems (LDAS) used within a GMP, ...