澳大利亚注册GMP合规性-国外生产商

AustralianRegulatoryGuidelinesGoodManufacturingPractice(GMP)ClearanceforOverseasManufacturers17thEditionVersion1.0May2011TherapeuticGoodsAdministrationCopyright©CommonwealthofAustralia2011Thisworkiscopyright.ApartfromanyuseaspermittedundertheCopyrightAct1968,nopartmaybereproducedbyanyprocesswithoutpriorwrittenpermissionfromtheCommonwealth.RequestsandinquiriesconcerningreproductionandrightsshouldbeaddressedtotheCommonwealthCopyrightAdministration,AttorneyGeneral’sDepartment,NationalCircuit,BartonACT2600orpostedat(TGA)·TheTGAisadivisionoftheAustralianGovernmentDepartmentofHealthandAgeing,andisresponsibleforregulatingmedicinesandmedicaldevices.·TGAadministerstheTherapeuticGoodsAct1989(theAct),applyingariskmanagementapproachdesignedtoensuretherapeuticgoodssuppliedinAustraliameetacceptablestandardsofquality,safetyandefficacy(performance),whennecessary.·TheworkoftheTGAisbasedonapplyingscientificandclinicalexpertisetodecision-making,toensurethatthebenefitstoconsumersoutweighanyrisksassociatedwiththeuseofmedicinesandmedicaldevices.·TheTGAreliesonthepublic,healthcareprofessionalsandindustrytoreportproblemswithmedicinesormedicaldevices.TGAinvestigatesreportsreceivedbyittodetermineanynecessaryregulatoryaction.·Toreportaproblemwithamedicineormedicaldevice,pleaseseetheinformationontheTGAwebsite.TherapeuticGoodsAdministrationGMPClearanceforOverseasManufacturers,17thEditionVersion1.0,May2011Page3of39VersionhistoryVersionDescriptionofchangeAuthorEffectivedateV1.0NewDocumentOfficeofManufacturingQuality12/05/11TherapeuticGoodsAdministrationGMPClearanceforOverseasManufacturers,17thEditionVersion1.0,May2011Page4of39ContentsIntroduction6TGAContactDetails______________________________________________________________________8Regulatoryinformation__________________________________________________________________81.ResponsibilitiesofAustraliansponsorsofmedicinesmanufacturedoverseas92.GMPClearanceprocess11Figure1-OverviewoftheGMPclearanceprocess__________________________________112.1.GMPClearanceapplicationrequirements______________________12GMPClearance_________________________________________________________________________12RenewingaGMPClearance___________________________________________________________12ChangestoaGMPClearance__________________________________________________________12ExtensionofaGMPClearance_________________________________________________________132.2.PathwaysforobtainingGMPClearance_________________________13GMPClearancesissuedunderaMutualRecognitionAgreements(MRA)__________14GMPClearancesissuedthroughGMPComplianceVerification(CV)_______________14TGAon-siteaudit______________________________________________________________________142.3.Identifyandobtaintherequireddocumentation_____________15Table1(a)–Requiredassessmenttype______________________________________________15Table1(b)–Documentaryevidencerequirements__________________________________16Generaldocumentaryrequirements__________________________________________________17GMPCertificates_______________________________________________________________________18Manufacturer’sdeclarationsforActivePharmaceuticalIngredients_______________19DocumentsforaTGAon-siteaudit___________________________________________________19Sharingofdocumentaryevidencebetweensponsorsandmanufacturers_________192.4.Submitapplicationandpayfees_________________________________20LodginganapplicationforclearancebyMRAandComplianceVerification_______20FailuretoprovideadequateGMPevidence__________________________________________21Paymentofapplicationfees(forMRAandCV)______________________________________21LodginganapplicationforaTGAon-siteaudit______________________________________21FeesforTGAon-siteaudit_____________________________________________________________21Scheduleoffees________________________________________________________________________21TherapeuticGoodsAdministrationGMPClearanceforOverseasManufacturers,17thEditionVersion1.0,May2011Page5of392.5.TGAassessment____________________________________________________22Targettimeframes_____________________________________________________________________222.6.OutcomesofTGAassessment_____________________________________22Clearanceapproval____________________________________________________________________22ConditionalClearance_________________________________________________________________22Rejectionofanapplication____________________________________________________________223.MaintenanceofaClearance23Clearanceexpiry_______________________________________________________________________234.Revocationorreductioninscopeofaclearance24Appendices25AppendixA-Glossaryofterms__________________________________________25AppendixB–Internationalagreements________________________________29AppendixC-Explanatorynotesfordocumentaryevidence_________31GMPAgreementswithmanufacturers_____________________________________________