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首页 Quality Agreement Guideline_final_December 2009_…

Quality Agreement Guideline_final_December 2009_clean_appendix A.doc

Quality Agreement Guideline_fin…

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2018-09-10 0人阅读 0 0 0 暂无简介 举报

简介:本文档为《Quality Agreement Guideline_final_December 2009_clean_appendix Adoc》,可适用于医药卫生领域

APICQualityAgreementTemplate(GenericAPIs)AppendixA:QualityAgreementTemplateforGenericAPIs(ComplianceSectiononly)Note:theterm“genericAPI”isusedinthistemplateforallAPIsthatinprinciplecanbeobtainedfrommultiplesources,oraremanufacturedandsuppliedtomultiplecustomers,asopposedtoAPIsthataresoldonlybytheoriginatorcompanyoritsexclusivelicenseesSuchgenericAPIsareoffpatenttheyareusuallydescribedinpharmacopoeialmonographs,andsuppliedbasedonstandardspecificationsApplicableGMPStandardSUPPLIERshallmanufacturetheSUBSTANCE(s)listedinAppendixXincompliancewiththeICHQGuideCertificateofAnalysisConformance(optional)ACertificateofAnalysisandaCertificateofConformance(optional)arerequiredforeachbatchofSUBSTANCEshippedtoCUSTOMERTheCertificatesofAnalysisandConformance(optional)shallbedatedandsignedbyaresponsiblepersonoftheSUPPLIER’sQualityUnit,oritmaybeproducedbyacomputersystemwhichprovidesadegreeofcontrolequivalenttothatgivenbyasignatureTheCertificateofAnalysisstatesthatthebatchissuitableforrelease,anditmustinclude–asaminimum–·SUPPLIERnameandaddress,incltelephonenumber·Nameandaddressoforiginalmanufacturer,ifSUPPLIERisnottheoriginalmanufacturer·SUBSTANCEnameandgrade(ifapplicable),·SUPPLIERbatchlotnumber,·Referencetotheagreedspecification,·Testparametersandcorrespondingspecificationrequirements,·Testresults(numerical,whereapplicable)foreachchemical,physicalormicrobiologicaltestperformed,·DateofreleaseandexpirationorretestdateoftheSUBSTANCENote:thedateofmanufactureisconsideredasoptionalOptional:TheCertificateofConformancestatesthatthesubjectlotwasproducedinaccordancetotheapplicableDMF,CEPorpharmacopoeialmonograph(s),andincompliancewithallapplicablecGMPrequirementsCertificateofAnalysisandCertificateofConformancemaybeissuedasseparatedocumentsorcombinedtoasingledocument,asappropriateNote:theCertificateofAnalysismaybeattachedasanappendixinanycaseitshouldmatchtheSUBSTANCEspecificationChangeControlSUPPLIERshallhaveadocumentedandeffectivechangecontrolsysteminplaceSUPPLIERshallinformCUSTOMERofanysignificantchangestothemanufactureoftheSUBSTANCE,whichmayhaveanimpactonthequalityofsuppliedSUBSTANCE,andoronanyregulatoryapplicationsrelatedtotheSUBSTANCESUPPLIERshallnotifyCUSTOMERwithinareasonabletime,priortoimplementation,toallowCUSTOMERtoassessthepotentialimpactofthechangeupontheSUBSTANCEsuppliedoritsusebyCUSTOMERTheimplementationofmajorchanges(ie,changesrequiringauthorities’preapproval)shallnotoccuruntiltheCUSTOMERhasgivenwrittenapprovalSUPPLIERshallonlysupplyCUSTOMERwithSUBSTANCEapprovedunderanyapplicableDMFandorCUSTOMER'sexistingregulatoryfilingsuntilsuchtimeastheSUBSTANCEmanufacturedfollowingsuchchangeispermittedundertheregulatoryfilingsthereforeForthosechangesrequiredtocomplywithapplicablelawsandregulatoryagencyrequirements,SUPPLIERshallnotifyCUSTOMERofsuchrequirementsafterSUPPLIERbecomesawareoftheneedforsuchchangeCUSTOMERundertakestosubmitwithinareasonableperiodoftimeallnecessarychangenotificationstoallcompetentauthoritiesinfullcompliancewiththeapplicableregulations,respectively,andtoinformSUPPLIERofthereceiptofthenecessaryacknowledgementofthevalidityofthenotificationand,dependingonthetypeofchange,theacceptanceorapprovalofthechangebythecompetentauthoritiesRighttoAuditSUPPLIERshallallow–uponsignatureofaspecialconfidentialityagreement–CUSTOMERoritsrepresentativestocarryoutonsiteauditsbyappointmentSUPPLIERshallpermitallreasonableaccesstothemanufacturing,packaging,warehousingandlaboratoryareasrelatedtothemanufactureoftheSUBSTANCE(s),includingpertinentdocumentationAnysuchauditshalltakeplaceduringnormalbusinesshoursandmustnotinterferewithSUPPLIER’smanufacturingoperationsTheresultsoftheauditandtheobservation(s)shallbesenttoSUPPLIERbymeansofawrittenreportSUPPLIERmustensureasatisfactoryfollowuptotheobservationsmadeduringtheauditperformedbytheCUSTOMER,andtakecorrectiveactionsmutuallyagreeduponbythepartiesNote:targettimelinesforbothreportandresponsemaybeaddedaweeksperiodisquitecommon,respectivelyTheauditfrequencyshalldependupontheresultsofthepreviousaudit(s)andthequalityperformanceofSUPPLIERIntheabsenceofcriticalqualityincidentsthefrequencyshallbenotmorethanonceeverythree()yearsAuthorityInspectionsSUPPLIERshallpromptlynotifyCUSTOMERofanyregulatoryorcGMPviolations(egFDAWarningLetterorsuspensionwithdrawalofoneormoreCEPs)identifiedduringauthoritycGMPinspectionsandimpactingthequalityoftheSUBSTANCEintendedtobeshippedtoCUSTOMERandorpotentiallyaffectingtheabilityofSUPPLIERtoproduceorshiptheSUBSTANCESubcontractingSUPPLIERwilluseitsestablishedcGMPsystemsforevaluation,approvalandmaintenanceofallsubcontractedserviceswithacGMPimpactonSUBSTANCEmanufacturedSUPPLIERshallnotifyCUSTOMERofanyexistingornewsubcontractorusedforanycGMPrelevantserviceiftheregulatoryfilingsoftheSUBSTANCEareconcernedRetentionofsamples(finalSUBSTANCE)Note:oneofthetwoconditionsgivenbelowshouldbechosen,dependingifanexpirydateoraretestdatehasbeendefinedfortheSUBSTANCESUPPLIERwillstoreSUBSTANCEretentionsamples,sufficienttoperformatleasttwo()fullspecificationanalyses(seeNote),incontainersthatareequivalenttoormoreprotectivethanthecommercialpackagingSamplesaretoberetainedfor<one()yearaftertheexpirydateofthebatchassignedbySUPPLIERorforthree()yearsafterdistribution,whicheveristhelonger>or<forthree()yearsafterthebatchiscompletelydistributedbySUPPLIER>Note:“specificationanalysis”means“analysisaccordingtotheagreedspecification”thatmaybeidenticalwith“compendialanalysis”(ifspecificationisequivalenttocurrentpharmacopoeialmonograph),ordifferentincasethereisnopharmacopoeialmonograph,oriftheagreedspecificationexceedsthemonographRetentionofrecordsdocumentationNote:oneofthetwoconditionsgiveninshouldbechosen,dependingifanexpirydateoraretestdatehasbeendefinedfortheSUBSTANCESUPPLIERwillstoretheoriginalmasterbatchrecords,theexecutedbatchrecords,andallotheroriginaldocumentationthatisrelatedtothemanufactureofsubstanceandthatisrequiredtobemaintainedundercGMP,protectedfromdestructionandunauthorisedaccess,for<one()yearaftertheexpirydateofthebatchassignedbySUPPLIERorforthree()yearsafterdistribution,whicheveristhelonger>or<forthree()yearsafterthebatchiscompletelydistributedbySUPPLIER>SUPPLIERwillmaketheoriginalrecordsrelatedtothemanufactureoftheSUBSTANCEavailableforCUSTOMERduringanonsiteauditValidationdocumentsshouldbearchivedforaslongasSUBSTANCEissuppliedorforyearsaftertheversionbecameobsoleteNote:aperiodofyearsisrecommendedbytheAPIC“Howtodo”DocumentontheICHQguidelineAyearsperiodisalsooftenusedStabilitySUPPLIERhasassignedretestdates(orexpirydates,whereapplicable),storageandshippingconditions,baseduponstabilitystudiesSUPPLIERisresponsibleforperformingongoingstabilitystudiesfortheSUBSTANCEAtleastonebatchperyearshouldbetestedtoICHrequirements(longtermstorageconditionsonly)Note:incasetheSUBSTANCEisnotmanufacturedinacertainyeartheaboverequirementisnotapplicableSUPPLIERisresponsibleforperformingappropriatestabilitystudiesontheSUBSTANCEarisingfromprocesschangesSUPPLIERwillprovidestabilitydatatoCUSTOMERuponreasonablerequest(eg,ifrequiredaccordingtotheappliedregistrationprocedure)Note:ResultsoftheongoingstabilityprogramarenotroutinelyprovidedtocustomersComplaintsSUPPLIERwillrespondtocomplaintsbytheCUSTOMERinatimelymannerandaccordingtoformallyagreedproceduresSUPPLIERwillinformCUSTOMERinatimelymannerandinwritingontheconclusionsdrivenbytheinvestigationperformedandthecorrectivepreventiveactionsdefinedIncasetheinvestigationcouldnotbefinalizedwithinbusinessdays,SUPPLIERwillprovideaninterimreporttoCUSTOMERNote:targettimelinesforbothinitialandconcludingresponsesmaybeaddedfortheconcludingresponseaperiodofbusinessdaysisquitecommonCUSTOMERwillmakerelevantinformationandsamplesoftheaffectedSUBSTANCEbatch(es)lot(s)availabletoassistintheinvestigationofSUPPLIER(asappropriate)SUPPLIERwillinformCUSTOMERifanyreceivedcomplaintcouldalsohaveaseriousimpactonbatchessuppliedtoCUSTOMER(ie,thecomplaintconstitutesapotentialrisktopatients’healthorsafety)ThestatutoryandorcontractualobligationsofCUSTOMERtoinspectthegoodsupondeliveryandtopromptlynotifyanydefectorshortageremainunaffectedRecallImmediatelyafterSUPPLIERhasbecomeawareofit,SUPPLIERwillinformCUSTOMERofanyseriousqualityissuethatmayresultinarecallofsuppliedSUBSTANCEorfinisheddrugproductmadethereofSUPPLIERandCUSTOMERconsultanddecideonrolesandresponsibilitiesregardingcoordinationoftheinvestigationanddecisionsCUSTOMERisresponsibleforthefinaldecisionandthecoordinationofanyrecallsorfieldalertactivitiesrelatedtofinisheddrugproduct,whereasSUPPLIERshallnotbeprohibitedhereunderfromtakinganyactionthatisdeemednecessarybasedonscienceandriskorthatisrequiredtobetakenbyapplicablelawProductqualityreviewSUPPLIERshallallowCUSTOMERtoreviewtheannualProductQualityReview(PQR)fortheSUBSTANCE(s)duringanonsiteauditStorageanddistributionNotes::Storage:specialstoragerequirementsfortheSUBSTANCE(s)shouldbeclear:Distribution:eitherintheSupplyAgreementorintheQualityAgreementtheresponsibilitiesforthewholesupplychainshouldbedefinedreferencetoGDP(IPEC,WHO)isrecommendedThefollowingtextiswrittenforacasewheretheSUPPLIERisresponsibleforthetransportationfromthemanufacturingsitetotheCUSTOMER’sreceivingsite(andneedstobechanged,ifresponsibilitiesaredifferent)SUPPLIERshallmakecommerciallyreasonableeffortstoexclude,duringpackaging,storage,andshippingoftheSUBSTANCE(s),thepossibilityofdeterioration,contamination,ormixupswithanyothermaterialSUPPLIERshallcomplywiththefollowingrequirementsinrelationtodistributionoftheSUBSTANCE(s):·Distributioninaccordancewithstorageconditionsstatedonthelabels·Contractswithhauliersandshippingagents·AbilitytorecallSUBSTANCEfromdistributionnetwork·QuarantineSUBSTANCEwithquestionablequality·Utilisetamperevidentsealsonallpackaging·SUPPLIERwillqualifyhauliersandshippingagentsusedtotransporttheSUBSTANCE(s)SUPPLIERwillprovideanuptodateMSDStoCUSTOMERwitheachshipmentoratleastonanannualbasisThisagreementdoesnotabsolvetheSUPPLIERfromcomplyingwithanylegalrequirementsinrelationtothetransportationoftheSUBSTANCE(s)UndesirablecontaminantsNote:thethreeitemslistedbelowconstitutethemostfrequentlyrequestedonesOthersmaybeaddedasappropriateBSETSESUPPLIERshallprovidetoCUSTOMERaBSETSEcertificatefortheSUBSTANCE(s)listedinaccordancewiththeEMEANoteforGuidanceEMEA(currentrevision)ThecertificateshallindicateiftheSUBSTANCE(s)is(are)ofhumanoranimalorigin,andifmaterialsofhumanoranimaloriginareusedduringthemanufacturingprocessoftheSUBSTANCE(s)AnupdatedBSETSEcertificatemustbeissuedafteranychangetothemanufacturingprocesswhichinvolvesnewrawmaterialsorforrawmaterialsthathavebeensourcedfromadifferentsupplierResidualsolventsSUPPLIERshallprovidetoCUSTOMERaresidualsolventsstatementfortheSUBSTANCE(s)listedinaccordancewiththeICHQCguidelineAnupdatedstatementmustbeissuedafterchangestothemanufactureoftheSUBSTANCE(s),ifapplicableMetalcatalystreagentresiduesSUPPLIERshallprovidetoCUSTOMERastatementonmetalresiduesfortheSUBSTANCE(s)listedinaccordancewiththeEMEA“Guidelineonthespecificationlimitsforresiduesofmetalcatalystsormetalreagents”(EMEACHMPSWP)andotherapplicableregulationsAnupdatedstatementmustbeissuedafterchangestothemanufactureoftheSUBSTANCE(s),ifapplicableIftheCEPcontainstherequiredinformationonBSETSE,residualsolventsormetalcatalystreagentresidues,thentheCEPitselfmaybeusedinsteadofseparatesupplierdeclarationsHAPIsSUPPLIERshallnotconductproductionandhandlingofhighlysensitizingmaterials(suchaspenicillinsorcephalosporins)intheequipmentbeingusedfortheSUBSTANCE(s)ProductionofsuchmaterialsinthesamebuildingbeingusedfortheSUBSTANCE(s)ispermittedonlyifperformedinaclosedanddedicatedsystemIncaseofhighlyactiveortoxicmaterials,suchaspotenthormones,cytotoxiccompounds,orotherpotentiallyhazardousmaterialsmanufacturedbytheSUPPLIERinthesamefacilitiesasusedforSUBSTANCE,validatedinactivationandorcleaningproceduresshouldbeinplaceRawmaterialsNAQualificationValidationNANote:qualificationandvalidationactivitiesaccordingICHQ,chapternotnecessarytogivemoredetailsintheagreementReprocessingNANote:nottobeincludedintheagreementreprocessingshallbeperformedaccordingtotheregistrationdossierandICHQ,chapterNofurtherinformationonreprocessingnecessaryasfarasdescribedintheDMForCEPdossier(genericAPIs)IfICHQaswellastheregisteredproceduresarefollowedthereisactuallynojustifiedreasontorefusethedeliveryofreprocessedbatchesofSUBSTANCEReworkingReworkingmustbeperformed,ifatall,accordingtotheSUBSTANCEregistrationdocuments,ifitispartofthedossier,oraccordingtoICHQ,chapterCUSTOMERshouldbeinformedofsuchbatcheslotsNote:onagreementreworkingmightbeprohibitedDeviationsOOS(inclstability)IncaseofseriousqualityincidentsobservedonlyaftershipmentofbatchesoftheSUBSTANCE,SUPPLIERshallpromptlyandappropriatelynotifyCUSTOMERthereofNote:informationonOOSresultsinstabilityisonlynecessaryifthereisanimpactontheretestperiodorthestorageconditionorthepackagingmaterial(suchinformationwouldbegiventhroughachangecontrolprocedureanywayseealsosection)PackagingInadditiontotherequirementsinICHQthefollowingshallapplytothepackagingoftheSUBSTANCE(s):ThespecificationsforpackagingmaterialsincludingtamperevidentsealsmustbeinaccordancewiththeregulatorydocumentationrelatedtotheSUBSTANCE(s)Optional:SUPPLIERshallpackagetheSUBSTANCEusingthecomponents,closuresandtamperevidentsealsasspecifiedinAppendixXNote:thelistinAppendixXmayincludebothprimarypackagingmaterialsandsecondaryones,egpallets,wrappingetcTheremaybetheneedtodefineandexplainanycodingontheseals<Listothersecuritymeasureshere,asapplicable>Note:thefollowingparagraphisonlyapplicableinveryspecificcasesOptional:WhenprimarypackagingmaterialisreturnedfromCUSTOMERtoSUPPLIERforreuse,SUPPLIERwillvalidatethecleaningprocedure(s)usedtocleanthepackagingmaterialLabellingNANotes::theshippinglabelmayincludeadditionalinformation(eg,CUSTOMERmaterialcode)detailsmaybedefinedintheSupplyAgreement:labellingshouldbedescribedinsufficientdetailifdoneonbehalfoftheCUSTOMER:anexampleofthelabelmaybeprovidedinanappendixtotheQualityAgreementRegulatorydocumentsSUPPLIERisresponsibleforpreparation,submissionandmaintainingtheappropriateregistrationdocumentsfortheSUBSTANCE(iedossierforCEP,DMF,orequivalent)SUPPLIERisresponsibleforallregulatorycontactswiththerelevantregulatoryauthoritywithjurisdictionovertheSUBSTANCEUponwrittenrequest,SUPPLIERwillallowCUSTOMERtorefertoSUPPLIER’sregistrationdocumentsfortheSUBSTANCE,inordertosupportCUSTOMER’sMarketingAuthorisationApplicationsforfinisheddrugproductmadefromSUBSTANCESUPPLIERwillprovidecurrentinformationtoCUSTOMER,asreasonablyrequestedfortheSUBSTANCEbyguidanceforsubmissionofanyregulatorydossierbyCUSTOMERforfinisheddrugproductmadefromSUBSTANCESuchinformationwillincludeeitheraccesstoCEP(includingtheappropriatestabilitydatafortheSUBSTANCE,ifnoretestdateisdefinedintheCEP),orapplicantsparttoDMF,orequivalentCUSTOMERisresponsibleforsubmittingtheregulatorydossierforMarketingAuthorisationApplicationassociatedwithanyfinisheddrugproductsmadefromtheSUBSTANCESuchregulatorydossier,asitpertainstoSUPPLIER,willrefertoSUPPLIER’sCEP,DMForequivalent,whereapplicableOptional:AppendixXwillincludethelistofSUPPLIER’ssupportiveregistrationdocumentsthatareavailableatthesignatureofthisQualityAgreementProductreleaseOptional:SUPPLIERwillnotshipanySUBSTANCEtoCUSTOMERuntiltheSUBSTANCEisreleased,unlesspriorwrittenapprovalhasbeenreceivedfromCUSTOMERtoperformsuchashipmentunderquarantineReferencestandardsAllreferencestandardsshouldbestoredinaccordancewiththesuppliersrecommendedstorageconditionsandusedwithintheirgivenexpiryorretestdateSUPPLIERshallprovidetoCUSTOMERreasonablequantitiesofanynoncompendial,commerciallynotavailablereferencestandardsnecessarytoperformthetestsincludedintheSUBSTANCEspecificationSpecificationsSpecificationsfortheSUBSTANCE(s)aredetailedinAppendixXAnalyticalmethodsSUPPLIERshallprovidetoCUSTOMERanyinhousemethods,includingvalidationreports,usedfortestingaccordingtotheagreedspecifications(wheretherearenocompendialmethods)CompendialanalyticalmethodsmustbeverifiedandallothersmustbevalidatedpriortouseAnnex:DivisionofResponsibilitiesC=CUSTOMERS=SUPPLIERARegulatoryComplianceCSAdheretoapprovedregistrationdocumentation(MarketingAuthorisation,NDA,IND,DMF,CEP,etc,asapplicable)XXMaintainingvalidmanufacturinglicense(s),asapplicableXMaintainingsitemasterfile,asapplicableXInformonsignificantchangesXSubmittingchangenotificationsapplicationstoauthoritiesXBPurchasing,ManufacturingandAnalyticalTestingofAPIStartingMaterials(SMs),RawMaterials,ProcessAids,Intermediates,andSUBSTANCESettingspecificationsforSUBSTANCE,materialsandintermediatesXPurchasingmaterialsaccordingtospecificationsXQualifyingandmonitoringmaterialsuppliersXSamplingandtestingofincomingmaterial,asappropriateXGeneratingandapprovingMasterBatchProcedureRecordXManufacturingSUBSTANCEaccordingtoMasterBatchProcedure(inclreprocessing,packaging,labelling)XPerformingbatchrecordreviewXAssigningbatchnumbersXSampling,testing,andreleasingofintermediatesandSUBSTANCEXPerformingIPCsXStoringretentionsamplesXDocumentingalldeviations,investigatingOOSandcriticaldeviationsXMaintaining(certified)referencestandardsXCPurchasingandTestingofPackagingMaterialXDLabelling,LabelPrintingandLabelReconciliationXEStorageandShipmentStoringAPIunderlabelledconditionsXXMaintainingstorageconditionsduringtransportationuntilagreedtransitionpointXFDocumentationCSEstablishingsynthesisscheme(includingdefinitionofAPISMs)XArchivingtheoriginalmanufacturingandcontroldocumentsXIssuingCertificateofAnalysisCertificateofConformance(optional)XPreparingreportsonOOS,criticaldeviationsXProvidingtestprocedures,qualitystatements,stabilityreports,andotherdocumentsasmutuallyagreedbetweenthepartiesXGEquipmentCleaningXHQualificationValidationQualifyingofequipment,utilitiesandfacilitiesXValidatingthemanufacturingprocess,cleaningprocedures,analyticalmethods,andcomputerisedsystemsXIStabilityProgramPerformingstabilitystudies,inclongoingstabilitystudies,underICHconditions(incltesting)XAssigningretestperiod(orshelflife)XXKProductQualityReviewXLComplaintsandRecallInvestigatingcustomercomplaintsrelatedtoSUBSTANCEXImplementingcorrectiveactions,ifnecessaryXRespondingtocustomer(s)XDecidingtoinitiaterecallX)X)Notifyingauthorities,externalcustomers,orconsumersX)X)ClarifyingrootcauseXXStoringordisposingreturnedproductX)X)MSubContractingQualifyingandmonitoringsubcontractorsX)ResponsibilityregardingdrugproductmadefromSUBSTANCE)ResponsibilityregardingSUBSTANCECopyright©ActivePharmaceuticalIngredientsCommittee(APIC)Version–DecemberPage

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