EDQM认证程序及其在中国的现场检查要求

UnderstandingUpdatedEDQMCertificationProcedureandFirstHandExperienceWithRegardstoOn-siteAPIInspectionsinChinaCPhIChinaConference27June2012DrFlorenceBENOIT-GUYOD,EDQM,CouncilofEuropeDrFlorenceBenoit-Guyod©2012EDQM,CouncilofEurope,Allrightsreserved2Overview•TheEUGMPforAPIs•InternationalAPIinspectionprogramme•What’snew?•Maindeficiencies•Statistics:activityreview,compliancetrends•EDQMcommunicationinChinaandfutureoutlookDrFlorenceBenoit-Guyod©2012EDQM,CouncilofEurope,Allrightsreserved3Responsibilityofthemarketingauthorisationholder(MAH)ofthemedicine•APIsmustbeproducedaccordingtoEUGMP(Directives2001/83/ECand2001/82/EC)•ItistheresponsibilityofthemanufacturertoensureEUGMPcomplianceoftheactivesubstancemanufacturer•DeclarationoftheQualifiedPerson(QP)ofthemanufacturerinthemarketingapplication(andsubsequentvariation)DrFlorenceBenoit-Guyod©2012EDQM,CouncilofEurope,Allrightsreserved4RoleoftheNationalCompetentAuthorityinEU•TheCompetentAuthoritymayinspectanAPImanufacturerinordertoensurethatthemanufacturingauthorisationholderofamedicinalproducthasfulfilleditsobligationsunderArticle46(f)and/orArticle50(f)ofthebelowmentionedDirectives(Article111ofDirective2001/83/ECandArticle80ofDirective2001/82/EC)•NB:incontrasttomedicines,inspectionsarenotcarriedoutsystematicallyDrFlorenceBenoit-Guyod©2012EDQM,CouncilofEurope,Allrightsreserved5Responsibilityofthemanufacturer•IntheCEPproceduretheAPImanufacturerhastodeclare:-CompliancetoGoodManufacturingPractices(GMP)-WillingnesstobeinspectedDrFlorenceBenoit-Guyod©2012EDQM,CouncilofEurope,Allrightsreserved6Conditionsforaninspection•WhenrequestedbyamemberState,EMA(Europeanmedicinesagency),EuropeanCommissionorEDQM(iftherearegroundsforsuspicionofnon-compliance,needtoverifydatasubmitted)•WhenrequestedbythemanufactureritselfDrFlorenceBenoit-Guyod©2012EDQM,CouncilofEurope,Allrightsreserved7EuropeanAuthoritiesEUROPEANDIRECTORATEFORTHEQUALITYOFMEDICINES(EDQM)EUROPEANUNION,EUROPEANCOMMISSION,DGEUROPEANMEDICINESAGENCY(EMA)NATIONALLICENSINGAUTHORITIESGMPINSPECTORATESDrFlorenceBenoit-Guyod©2012EDQM,CouncilofEurope,Allrightsreserved8GMP/GDPInspectorsWorkingGroup•TakesplaceatEMA,London•GathersEEAmemberstatesrepresentatives•Providesinputandrecommendationsonallmattersrelatingto-GoodManufacturingPractice(GMP)-GoodDistributionPractice(GDP)DrFlorenceBenoit-Guyod©2012EDQM,CouncilofEurope,Allrightsreserved9GMP/GDPInspectorsWorkingGroup:mainactivitiesrelatingtoGMP–DiscussionsofEULegislation–EudraGMPdatabase–GMPforMedicinalProducts(PartI,Annexures)–GMPforActiveSubstances(PartII,Annexures)–GDP–Productdefects&inspectionsundercentralisedprocedure–ManagementofMRAinthefieldofGMP–ICHQ8,Q9andQ10implementation–ManagementoftheCommunityProceduresDrFlorenceBenoit-Guyod©2012EDQM,CouncilofEurope,Allrightsreserved10RoleofEMA:CompilationofProcedures•EMAisresponsibleformaintainingandpublishingonbehalfofECCommission•CollectionofGMPinspection-relatedproceduresandforms(QualitySystemforGMPInspectorates)agreedbyallmemberstates•Tofacilitate:–Collaboration–Harmonisation–ExchangeofInformationRoleofEMA:CompilationofproceduresEMA/INS/459921/2010-QualitysystemsframeworkforGMPinspectorates-Proceduresrelatedtorapidalerts-ProcedurerelatedtoGMPinspections-ProceduresrelatedtoGDPinspections-Formsusedbyregulators-Proceduresrelatedtocentralisedprocedures(onesinglereferenceforalldocumentssinceMarch2011)DrFlorenceBenoit-Guyod©2012EDQM,CouncilofEurope,Allrightsreserved12Sharingofinformation-APIprogram•InternationalAPIInspectionPrograminitiatedbyEMAin2007afterapproachingAuthorities:France,Germany,Italy,UK,EDQM,Australia,USFDA,Ireland•Allagreedtoparticipateinapilotphase=totalduration2years(end2010)•Aim:–TomakebestuseofInspectorate’sresources–ToincreasetheinspectionalcoverageDrFlorenceBenoit-Guyod©2012EDQM,CouncilofEurope,Allrightsreserved13Sharingofinformation-APIprogram•Confidentialityagreementssigned•Pilotprogramisbuiltupwithbilateralandgeneralteleconferences•Runningtheprogramisbasedon–Sharinginspectionreports–Performingjointinspections(withscopeextensionifnecessary)DrFlorenceBenoit-Guyod©2012EDQM,CouncilofEurope,Allrightsreserved14Sharingofinformation-APIprogram•Theparticipantstotheprogramprovidedalltogetheralistof1110sites(aspublishedin2011attheendofthepilotphase)•Asseveralsitesweresharedsites,therewereatotalof646siteslistedfromwhich:•408siteswereofinteresttoonlyoneoftheparticipants•238wereofinterestto2or3oftheparticipants•USFDAhastakenanimportalertdecisionbasedonanEDQMinspectionwithnegativeoutcome•Nextsteps:–Tocontinuetheprogram(nolongerpilot)withteleconferences,informationexchange–Toimproveprocessmonitoring–ToenlargethenumberofparticipantsDrFlorenceBenoit-Guyod©2012EDQM,CouncilofEurope,Allrightsreserved15EDQMInspectionprogramme•OptionalpartoftheCertificationProcedure(Article111ofDirective2001/83/ECandArticle80ofDirective2001/82/EC,CompilationofCommunityProcedures)•PerformedbeforeoraftertheCEPisgranted•Aim:toverifythecompliancewithsubmitteddossierEUGMPPartIIEUGMPAnnexes(e.g.Annex1/sterilesubstances)DrFlorenceBenoit-Guyod©2012EDQM,CouncilofEurope,