1 © World Health Organization WHO Technical Report Series, No. 961 , 201 1 世界卫生组织技术报告系列, 编号961, 2011 年 Annex 3 附录3 WHO good manufacturing practices for pharmaceutical products: main principles 世界卫生组织药品GMP主要原理 Introduction 介绍 General considerations 总则 Glossary 术语表...
WHO good manufacturing practices for pharmaceutical products: main principles 世界卫生组织药品GMP主要原理 Introduction 介绍 General considerations 总则 Glossary 术语表 Quality management in the medicines industry: philosophy and essential elements 药业的质量管理:理念和基本要素 ...
WHO TRS986 附录 2:WHO 药品 GMP 总则, 2014.pdf,Annex 2 WHO good manufacturing practices for pharmaceutical products: main principles1 Introduction 79 General considerations 80 Glossary 81 Quality management in the medicines industry: philosophy and esse
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(1). The Fifty-fifth...
(WHO)药品GMP主要原理 WorldHealthOrganizationWHOTechnicalReportSeries,No.986,2014世界卫生组织技术报告系列,编号986,2014年 编辑整理:Nancy2016.03.222 目录 Annex2WHOgoodmanufacturingpracticesforpharmaceuticalproducts:mainprinciples附录2世界卫 生组织药品GMP主要原理...1 Introduction介绍......
_中英文_附录2 WHO药品GMP指南
Annex 2 WHO good manufacturing practices for pharmaceutical products: main principles 附录2 WHO药品GMP:主要原则 Introduction引言 General considerations总则 Glossary术语 Quality management in the medicines industry: philosophy and essential elements 制药企业的质量管理:GMP 理念和基本元素 1. Pharmaceutical quality...
3.1. The recommendations in this guidelineare applicable to investigational products for human and veterinary use. 本指南的建议适用于人用和兽用临床试验药品。 3.2. Although the focus is on medicinal(pharmaceutical) products, some of the principles may be applied to otherinvestigational products. ...
11.3. Facilities, as listed below, should be subject to all GMP requirements for pharmaceutical products; 下表列出的设施应符合药品的所有GMP要求; • a large-scale production line assembled to manufacture materials in larger batches (e.g....
11 月 5 日,世界卫生组织(WHO)发布了“试验用药品GMP” 指南(Good manufacturing practices for investigational products)的征求意见稿。 该文件是对WHO GMP附录7的修订,目前正处于收集意见期,截止日期为2021年1月。此后,将于2021年2-3月份提交专家工作组,进行讨论,完善后进行第2轮意见收集。最终修订稿计划于2021...