2.Identifying the new landscape of Good’s Manufacturing Practice (GMP) regulations in China_DR WU KE

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1、AComparativeAnalysisofNewChineseGMPBravoBio上海博沃生物科技有限公司2011.04CheerstolifeSingapore,Aug2011Content-NewGMPvs.OldGMP;-NewChineseGMPvs.WesternGMPs(EuropeanGMPandUSGMP);-ImpactofnewChineseGMPonDomesticPharmaceuticalIndustry.NewGMPvs.OldGMPWhyNewVersionofGMP?LackofSystematicGuidelinefromo

2、ldGMPInsufficientHardwareCriteriafromoldGMPForRecognitionbyInternationalMarketTrendforglobalizationinpharmaceuticalIndustryNewGMPvs.OldGMPProfileofNewGMP-11.EmphasisonQualitySystemSimilartoEuropeanGMPandWHOCriteria*APIstandardsinannexesequivalenttoICHQ7AUSGMPEUGMPSimilartoChineseGMP

3、2.MoreScientific,Operable,TestableJAPANWHOGMPBasedonEUGMP3.ApplicationofComputerizedSystemNewGMPvs.OldGMPProfileofNewGMP-24.Moresophasticatedrequirementsonpersonnel1)educationbackground2)Experience3)Training4)Anovelconceptofkeypersonnel5)Introductionofqualitycontrolandqualityassurance

4、-Qualitymanagement-Qualityriskmanagement5.IntroductionofmorestrictdocumentationsystemNewGMPvs.OldGMPContentComparisonOldGMP(14Chapters,88articles)NewGMP(14Chapters,313articles)Chapter1,General2articlesChapter1,General4articlesChapter2,OrganizationandPersonnelChapter2,QualityManagement

5、11articles5articlesChapter3,PremisesandFacilitiesChapter3,OrganizationandPersonnel22articles23articlesChapter4,Equipment7articlesChapter4,PremisesandFacilities33articlesChapter5,Material10articlesChapter5,Equipment31articlesChapter6,Hygiene9articlesChapter6,MaterialsandProducts36artic

6、lesChapter7,Validation4articlesChapter7,QualificationandValidation12articlesChapter8,Documents5articlesChapter8,DocumentsManagement34articlesNewGMPvs.OldGMPContentComparison-2OldGMP(14Chapters,88articles)NewGMP(14Chapters,313articles)Chapter9,ProductionManagementChapter9,ProductionMan

7、agement33articles8articlesChapter10,QualityManagementChapter10,QualityControlandQualityAssurance3articles61articlesChapter11,ProductSalesandReturnChapter11,ContractManufacturingandInspection3articles15articlesChapter12,ComplaintandAdverseChapter12,ProductDistributionandRecallReactionR

8、eport