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
WHO发布《使⽤不同⽅法—包括HBEL—建⽴清洁验证限度指南》！Thanks for your attention 近⽇，WHO发布了新的清洁验证指南——《不同⽅法——包括HBEL——建⽴清洁验证的残留 限度以确定共⽤设施⽣产污染风险的考量》，该指南解读如下：传统的⽅法是进⾏清洁验证并基于GMP⽂件中建议的接受标准来...
WHO TRS981 附录 2-WHO 质量风险管理指南,2013.pdf,Annex 2 WHO guidelines on quality risk management 1. Introduction 62 1.1 Background and scope 62 1.2 Principles of quality risk management 64 2. Glossary 67 3. Quality risk management process 70 3.1 Initia
WHO_TRS_961 Annex2WHO药品微生物实验室管理规范 下载积分: 1000 内容提示: WHO 技术指南报告 No. 961, 2011, annex 2 WHO 药品微生物实验室管理规范 1 of 27 © World Health Organization 世界卫生组织 WHO Technical Report Series, No. 961, 2011 世界卫生组织技术报告系列,编号961 ,2011 年 Annex 2 ...
1. Introduction and background 介绍及背景 The World Health Organization (WHO) has published the guideline entitledGood ManufacturingPractices for pharmaceutical products: main principlesin the WHO TechnicalReport Series, No. 986, Annex 2, 2014(1). WHO 于 2014 年 TRS 986 附录 2 发布了题为“药品...
WHO TRS-996-附件3:生物制品生产质量管理规范(GMP)-中英对照.pdf,Annex 3附录3 WHO good manufacturing practices for biological products WHO生物制品生产质量管理规范(GMP) 1 Replacement of Annex 1 of WHO Technical Report Series, No. 822 代替WHO技术报告系列
961, 2011 Annex 10 附件 10 Procedure for prequalification of pharmaceutical products 药品的预认证程序1. Introduction 介绍2. Glossary 术语3. Purpose and principles 目的和原则4. Steps of the procedure 程序步骤5. Invitation for expressions of interest 表达兴趣的6. Data and information to be ...
WHO TRS 1022 第55 次 报告 Annex 3 Good manufacturing practices: water for pharmaceutical use 优良生产规范( GMP ): 制药用水 Background 背景 Unlike other product or process ingredients, water is usually drawn from an on demand system and is not subject to testing and batch or lot release pr...
WHO_TRS_929-Annex4[1]搜索 59© World Health OrganizationWHO Technical Report Series, No. 929, 2005Annex 4WHO guidelines for sampling of pharmaceuticalproducts and related materials1.Introduction1.1General considerations1.2Glossary1.3Purpose of sampling1.4Classes and types of pharmaceutical products and ...
1. Introductionand background 介绍及背景 The World HealthOrganization (WHO) has published the guideline entitled Good manufacturing practicesfor pharmaceutical products: main principles in the WHO Technical ReportSeries, No. 986, Annex 2, 2014 (1). WHO 于 2014 年 TRS 986 附录2 发布了题为“药品...