Annex5 Guidanceongooddataandrecordmanagementpractices Background Duringaninformalconsultationoninspection,goodmanufacturingpractices andriskmanagementguidanceinmedicines’manufacturingheldbythe WorldHealthOrganization(WHO)inGenevainApril2014,aproposalfor newguidanceongooddatamanagementwasdiscussedanditsdevelopment ...
961, 2011, annex 5 WHO GMP: 非无菌制剂的加热通风和空调系统的生产质量管理规范的补充指导原则 1 of 52 © 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 5 附件5 Supplementary guidelines on good manufacturing ...
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Annex3 WHOguidelinesonvariationstoaprequali,edproduct Introduction96 1.Background97 1.1Objectives97 1.2Scopeandapplication98 2.Guidanceforimplementation99 2.1Reportingtypes99 2.1.1Noti,cations100 2.1.2Minorvariation(Vmin)101 2.1.3Majorvariation(Vmaj)101 ...
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
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 ...
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 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...
who_trs_908-annex9 热度: 相关推荐 59 ©WorldHealthOrganization WHOTechnicalReportSeries,No.929,2005 Annex4 WHOguidelinesforsamplingofpharmaceutical productsandrelatedmaterials 1.Introduction61 1.1Generalconsiderations61 1.2Glossary61 1.3Purposeofsampling64 1.4Classesandtypesofpharmaceuticalproductsandrelated mat...
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...