Annex4 Supplementaryguidelinesongoodmanufacturing practices:validation 1.Introduction 2.Scope 3.Glossary 4.Relationshipbetweenvalidationandqualification 5.Validation 5.1.Approachestovalidation 5.2.Scopeofvalidation 6.Qualification 7.Calibrationandverification ...
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...
8.Recommendations to assure the quality, safety and efficacy of recombinanthepatitis B vaccines. WHO Technical report series No. 978. World HealthOrganization, Geneva, 2013. Available athttp://www.who.int/biologicals/vaccines/TRS_978_An...
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...
Annex5 Guidanceongooddataandrecordmanagementpractices Background Duringaninformalconsultationoninspection,goodmanufacturingpractices andriskmanagementguidanceinmedicines’manufacturingheldbythe WorldHealthOrganization(WHO)inGenevainApril2014,aproposalfor newguidanceongooddatamanagementwasdiscussedanditsdevelopment ...
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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 ...
eu gmp annex 11 中文 WHO GMP Sterile 2010 Annex 4 TRS957_2010.doc,eu gmp annex 11 中文 WHO GMP Sterile 2010 Annex 4 TRS957_2010 导读:就爱阅读网友为您分享以下“WHO GMP Sterile 2010 Annex 4 TRS957_2010”的资讯,希望对您有所帮助,感谢您对92的支持! Table 2
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 ...
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 ...