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 TRS981 附录 2-WHO 质量风险管理指南,2013.pdf,Annex 2 WHO guidelines on quality risk management 1. Introduction 62 1.1 Background and scope 62 1.2 Principles of quality risk management 64 2. Glossary 67 3. Quality risk management process 70 3.1 Initia
WHO TRS986 附录 2:WHO 药品 GMP 总则, 2014.pdf,Annex 2 WHO good manufacturing practices for pharmaceutical products: main principles1 Introduction 79 General considerations 80 Glossary 81 Quality management in the medicines industry: philosophy and esse
Geneva: World Health Organization; 2013: Annex 2 (WHO Technical Report Series, No. 981; https://www.who.int/medicines/areas/quality_safety/quality_assurance/Annex2TRS-981.pdf, accessed 8 February 2019). 本站仅提供存储服务,所有内容均由用户发布,如发现有害或侵权内容,请点击举报。
Geneva: World Health Organization; 2013: Annex 2 (WHO Technical Report Series, No. 981: https://www.who.int/medicines/areas/quality_safety/quality_assurance/Annex2 TRS -981.pdf?ua=1 , accessed 1 May 2020). 8. WHO Guidelines on validation. In: WHO Expert Committee on Specifications for ...
Annex3附录3 WHOgoodmanufacturingpracticesforbiologicalproducts WHO生物制品生产质量管理规范(GMP) 1 ReplacementofAnnex1ofWHOTechnicalReportSeries,No.822 代替WHO技术报告系列(TRS)822号附录1 1.Introduction简介6 2.Scope范围7 3.Terminology术语13 4.Principlesandgeneralconsiderations原则与总论23 5.Pharmaceutical...
Annex3,2015(3)). 119 WHOExpertCommitteeonSpecificationsforPharmaceuticalPreparationsFifty-thirdreport 1.Introduction121 2.Scope121 3.Glossary122 4.Relationshipbetweenvalidationandqualification124 5.Validation124 6.Documentation125 7.Validationmasterplan126 ...
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 ...
The overarching text presented in this annex constitutes the general principles of the new guidance onvalidation. 本附件中呈现的总体文本构成了新验证指南的一般原则。 The following appendices included in this annex address specific aspects of validation and are intended to complement the general text on...
Annex5 Guidanceongooddataandrecordmanagementpractices Background Duringaninformalconsultationoninspection,goodmanufacturingpractices andriskmanagementguidanceinmedicines’manufacturingheldbythe WorldHealthOrganization(WHO)inGenevainApril2014,aproposalfor newguidanceongooddatamanagementwasdiscussedanditsdevelopment ...