2.2 This guideline should be applied when transferring the technology of processes and procedures relating to active pharmaceutical ingredients (APIs), in-process bulk materials, finished pharmaceutical products (FPPs), process validation, cleaning procedure development and validation and analytical proced...
During these virtual meetings, a group of experts made a series of proposals for future activities, one of which was how to determine whether or not the WHO guidelines on the transfer of technology in pharmaceutical manufacturing (1) ...
WorkingdocumentQAS/0.869WHOguidelinesonthetransferoftechnologyinpharmaceuticalmanufacturingWorkingdocumentQAS/0.869WHO药品生产技术转移指南草案001翻译:JULIA译文供供参考页1/37DRAFTWORKINGDOCUMENTFORCOMMENTS:WHOguidelinesonthetransferoftechnologyinpharmace
12月4日,世界卫生组织(WHO)于发布《药品生产技术转移指南》(WHO guidelines on the transfer of technology in pharmaceutical manufacturing),提供了药品技术转让期间应考虑的指导原则。 Background 背景 During the Fifty-fifth World Health Organization (WHO) Expert Committee on Specifications for Pharmaceutical Prepa...
WHO关于药品和相关物料的抽样指导原则 WHO guidelines for sampling of pharmaceutical products and related materials 目录 1. 绪论 1.1 总体考虑 1.2 术语 1.3 抽样目的 1.4 药品和相关物料的类型和分类 1.5 抽样设备 1.6 抽样的职责 1.7 健康和安全 2. 抽样过程 2.1 抽样准备 2.2 抽样操作和注意...
guidelines arising from inspections carried out forCOVID-19 therapeutics, the World Health Organization (WHO) PrequalificationTeam-Inspection Services (PQT INS) raisedthe urgency for a revision of the WHO Good manufacturing practices forinvestigational pharmaceutical products for clinicaltrials in humans (...
WHO关于药品和相关物料的抽样指导原则 第1页共20页 WHO关于药品和相关物料的抽样指导原则 WHOguidelinesforsamplingofpharmaceuticalproductsandrelatedmaterials 目录 1.绪论 1.1总体考虑 1.2术语 1.3抽样目的 1.4药品和相关物料的类型和分类 1.5抽样设备 1.6抽样的职责 1.7健康和安全 2.抽样过程 2.1抽样准备 2.2抽样操作和...
This document is a revision of WHO Good manufacturing practices: water for pharmaceutical use , previously published in the WHO Technical Report Series, No. 970, Annex 2, 2011. 本文件是 WHO 技术报告 No. 970, 附件 2《 WHO GMP: 制药用水》 ,2011 年的修订 版。 目录 1. Introduction and ...
《WHO制药生产技术转移指南( WHO guidelines on the transfer of technologyin pharmaceutical manufacturing)》,该指南解读及全文翻译如下: 1、要求转移方和接收方都应该有一个适当设计、明确定义和书面的质量体系。质量体系应具备足够的资源,充分实施和维护。 2、要求质量体系应包含GxP,不单单是GMP。 3、应保留技术...
WHO最新指南:《药品生产技术转移指南》(中英文对照) PharmLink指南组 12月4日,世界卫生组织(WHO)于发布《药品生产技术转移指南》 (WHOguidelinesonthetransferoftechnologyinpharmaceutical manufacturing),提供了药品技术转让期间应考虑的指导原则。 本指南主体部分分为12个章节,内容如下: 背景 1.简介 2.范围 3.术语 ...