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 ...
Annex2WHOgoodmanufacturingpracticesfor pharmaceuticalproducts:mainprinciples 附录2世界卫生组织(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...
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...
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Annex5 Guidanceongooddataandrecordmanagementpractices Background Duringaninformalconsultationoninspection,goodmanufacturingpractices andriskmanagementguidanceinmedicines’manufacturingheldbythe WorldHealthOrganization(WHO)inGenevainApril2014,aproposalfor newguidanceongooddatamanagementwasdiscussedanditsdevelopment ...
961, 2011, annex 7 WHO 药品生产技术转移的指导原则 1 of 32 © 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 7 附录 7 WHO guidelines on transfer of technology in pharmaceutical manufacturing WHO 药品生产技术...
908, 2003Annex 9Guide to good storage practices forpharmaceuticals11.Introduction1252.Glossary1263.Personnel1284.Premises and facilities1285.Storage requirements1316.Returned goods1337.Dispatch and transport1338.Product recall134References134Bibliography134Appendix136Storage and labelling conditions1.IntroductionThis ...
WHO_TRS_961 Annex3 WHO GMP主要原理介绍.pdf,WHO GMP for pharmaceutical products: main principles WHO 技术指南报告No. 961, 2011, annex 3 WHO 药品GMP 主要原理 © World Health Organization WHO Technical Report Series, No. 961, 2011 世界卫生组织技术报告系列
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 relatedmaterials1.5Sampling facilit...