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首页 Inspections - Good Manufacturing Practice

Inspections - Good Manufacturing Practice.doc

Inspections - Good Manufacturin…

宗秦堂主
2018-09-08 0人阅读 举报 0 0 暂无简介

简介:本文档为《Inspections - Good Manufacturing Practicedoc》,可适用于医药卫生领域

InspectionsGoodManufacturingPracticeCompilationofCommunityProceduresonInspectionsandExchangeofInformationTheEMEAisresponsibleformaintainingandpublishingtheCompilationofProceduresonbehalfoftheEuropeanCommissionTheCompilationofProceduresisacollectionofGMPinspectionrelatedproceduresandformsagreedbytheGMPinspectoratesofalltheMemberStatesanddesignedtofacilitateadministrativecollaboration,harmonisationofinspectionsandexchangeofinspectionrelatedinformationArticleoftheGMPDirective,EC,requiresMemberStatestotakeaccountoftheseprocedures,andtheyareusedasthebasisforstandardoperatingproceduresofthequalitysystemsestablishedwithintheinspectoratesthemselvesZipfilecontainingallthedocumentsintheCompilation(filesize=MB)Individualdocumentscanbedownloadedusingthelinksbelow:TableofContentsandIntroduction:QualitySystemsFrameworkforGMPInspectoratesProceduresrelatedtoRapidAlerts:HandlingofreportsofsuspectedqualitydefectsinmedicinalproductsProcedureforHandlingRapidAlertsandRecallsArisingfromQualityDefectsProcedureforHandlingRapidAlertsandRecallsArisingfromQualityDefectspendingadoptionRapidAlertNotificationformRapidAlertFollowupformProceduresrelatedtoGMPInspections:ProcedurefordealingwithseriousGMPnoncomplianceorvoidingsuspensionofCEPSthusrequiringcoordinatedadministrativeactionpendingadoptionConductofInspectionsofPharmaceuticalManufacturersOutlineofaProcedureforCoordinatingtheVerificationoftheGMPstatusofManufacturersinThirdCountriesGuidelineonTrainingandQualificationsofGMPInspectorsExchangeofInformationonManufacturersandManufacturingorWholesaleDistributionAuthorisationsbetweenCompetentAuthoritiesintheEuropeanEconomicAreaExchangeofInformationformAppendix(requestforinformation)ExchangeofInformationformAppendix(replyform)GuidanceontheoccasionswhenitisappropriateforCompetentAuthoritiestoconductinspectionsatthepremisesofManufacturersofActiveSubstancesusedasstartingmaterialsTheissueandupdateofGMPcertificatesAmodelforriskbasedplanningforinspectionsofpharmaceuticalmanufacturersFormsusedbyRegulators:GMPInspectionreportCommunityformatHYPERLINK"http:wwwemeaeuropaeuInspectionsdocsCoCPCoCPGMPInspReportpdf"CommunityBasicFormatforManufacturersAuthorisationGMPCertificatecorrProceduresrelatedtoCentralisedProcedures:ProcedureforCoordinatingForeignandCommunityPreAuthorisationInspectionsduringtheAssessmentofApplicationsGuidelineonthePreparationofReportsonGMPInspectionsRequestedbyeithertheCHMPorCVMPinconnectionwithApplicationsforMarketingAuthorisationsandwithProductsauthorisedundertheCentralisedSystemDelegationofResponsibilitiesforGMPInspectionsforProductscoveredundertheCentralisedProcedureCompilationHistory:HistoryofchangestoCompilationofProcedures Sendallqueriesregardingthiscontentto:gmpemeaeuropaeu

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