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 ...
Annex2附件2 WHOgoodmanufacturingpractices:waterforpharmaceuticaluse WHOGMP:制药用水 1.Introduction介绍 1.1Scopeofthedocument文件范围 1.2Backgroundtowaterrequirementsanduses水的要求和使用背景 1.3Applicableguides适用的指南 2.Generalprinciplesforpharmaceuticalwatersystems制药用水系统的一般原则 ...
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
form85Appendix 3Steps to be considered for inclusion in a standard operating procedure87