12、WHO_TRS_981附录2:WHO质量风险管理指南-英-2013.pdf 关闭预览 想预览更多内容,点击免费在线预览全文 免费在线预览全文 Annex2 WHOguidelinesonqualityriskmanagement 1.Introduction62 1.1Backgroundandscope62 1.2Principlesofqualityriskmanagement64 2.Glossary67 3.Qualityriskmanagementprocess70 3.1InitiatingaQRM...
Annex 2 65 ■ Te level o efort, ormality and documentation o the QRM process should be commensurate with the level o risk. In addition to the two principles above, the ollowing principles are also part o the QRM methodology: ■ When applied, processes using QRM methodologies should be ...
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 ...
Annex2WHOgoodmanufacturingpracticesforpharmaceuticalproducts:mainprinciples附录2世界卫 生组织药品GMP主要原理...1 Introduction介绍...
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
[7] WHO. Evaluation of the quality, safety and efficacy of messenger RNA vaccines for the prevention of infectious diseases[EB/OL]. (2021-07-22)[2021-10-05]. https://www. who.int/publications/m/item/annex-3-mRNA-vaccines-...
Geneva: World Health Organization; 2013: Annex 2 (WHO Technical Report Series, No. 981; https://www.who.int/medicines/areas/quality_safety/quality_assurance/Annex2TRS-981.pdf, accessed 8 February 2019). 本站仅提供存储服务,所有内容均由用户发布,如发现有害或侵权内容,请点击举报。
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 ...
WHO Technical Report Series, No. 970, 2012 Annex 2 附件2Page 1 of 20 Annex 2 附件2 WHO good manufacturing practices: water for pharmaceutical use WHO GMP：制药用水 1. Introduction 介绍 1.1 Scope of the document文件范围 1.2 Background to water requirements and uses 水的要求和使用背景...
theWHOTechnicalReportSeries,No.986,Annex2,2014(1). WHO于2014年TRS986附录2发布了题为“药品GMP:主则”的指南。 TheWHOSupplementaryguidelinesongoodmanufacturingpractice:validationwerepublishedin2006andweresupportedbysevenappendices.The maintext(2)anditsappendixes(3,4,6,7,8,9)wererevisedbetween2006and2019....