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 ...
TRS822Annex1 TRS823Annex1 1 厂房的适宜性 4.1-4.4 11.1 2 明确划分和恰当掌握的区域 4.11;5.1 11.1;11.2; 11.7-11.17;11.29 3 防止有害物进入的设计 4.1 11.6 4 适当的铝材:管道和阀门 4.2 11.25 5 原材料、人员、产品和废弃物的流淌方向 4.4 ...
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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...
Annex5 Guidanceongooddataandrecordmanagementpractices Background Duringaninformalconsultationoninspection,goodmanufacturingpractices andriskmanagementguidanceinmedicines’manufacturingheldbythe WorldHealthOrganization(WHO)inGenevainApril2014,aproposalfor newguidanceongooddatamanagementwasdiscussedanditsdevelopment ...
内容提示: 171Annex 3IAEA/WHO guideline on good manufacturing practices for investigational radiopharmaceutical productsBackgroundIn view of the rapidly expanding fi eld of molecular imaging and targeted radiopharmaceutical therapy, combined with the absence of dedicated guidance specif i c to the ...
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 ...
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 ...
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...
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...