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...
WHO制药用水GMP指南-2020 下载积分: 200 内容提示: Working document QAS/20.842 May 2020 DRAFT WORKING DOCUMENT FOR COMMENTS : Good manufacturing practices: water for pharmaceutical use Please send your comments to Dr Sabine Kopp, Team Lead, Norms and Standards for Pharmaceuticals, Technical Standards ...
957 Annex 1) WHO GMP: main principles for pharmaceutical products. In: Quality assurance of pharmaceuticals. A compendium of guidelines and related materials. Vol. 2, 2nd updated edition. Good manufacturing practices and inspection (Geneva, World Health Organization, 2007) Guidelines for p 9、...
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
一、WHO预认证简介 二、WHOGPCL简介 三、中检院化学药品实验室预认证情况 四、WHO预认证及药品抽验相关实验室区域间研讨会五、全国药检系统质量管理体系建设 一、WHO预认证简介 •WHO预认证的目的 –增加质控实验室的数量:符合药品检验的相关标准并受委托为联合国机构进行药品检验;–促进发展中国家的国家...
_中英文_附录2 WHO药品GMP指南
1.7 This document should be read in conjunction with other WHO guidelines as referenced below (2-14), as well as other regulatory guidelines which include The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) Q7, Q8, Q9, Q10 and Q11. This...
An acronym for the group of good practiceguides governing the preclinical, clinical, manufacturing, testing, storage,distribution and post-market activities for regulated pharmaceuticals,biologicals and medical devices, such as GLP, GCP, GMP, good pharmacovigilancepractices (GVP) and good distribution prac...
Acronym for the group of good practice guides governing the preclinical, clinical, manufacturing, testing, storage, distribution and post-market activities for regulated pharmaceuticals, biologicals and medical devices, such as GLP, GCP, GMP, good pharmacovigilance practices (GPP) and good distribution ...
《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...