论药品生产验证总计划(英文版)VIP免费

PHARMACYMANUFACTURINGUNITVALIDATIONMASTERPLAN(VPM).GeneralNotesAimsofQualificationandValidationAnysignificantchangesto,premises,equipmentorprocesses,whichmayaffectthequalityofthefinalproduct,directlyorindirectly,shouldbequalifiedandvalidated.ThekeyelementsofaqualificationandvalidationprogramshouldbeclearlydefinedanddocumentedinaValidationMasterPlan.Theprocessshouldestablishandprovidedocumentaryevidencethat:premises,supportingutilities,equipmentandprocesseshavebeendesignedinaccordancewiththerequirementsofGMP.ThisnormallyconstitutestheDesignQualificationor‘DQ’andincludesconfirmationthatthepremises,supportingutilitiesandequipmenthavebeenbuiltandinstalledincompliancewiththeirdesignspecifications(thisconstitutesInstallationQualificationor‘IQ’)andthattheyoperateinaccordancewiththeirdesignspecifications(thisconstitutesOperationalQualificationorOQ).Aspecificprocesswillconsistentlyproduceaproductmeetingitspredeterminedspecificationsandqualityattributes(thisconstitutesProcessValidationorPV.ThetermPerformanceQualificationorPQmaybeusedalso).PurposeTheVMPisintendedtobea‘live’documentthatsupportsthedesignandconstructionofanyproductionfacility,itssubsequentoperation,maintenanceandchangestothefacilityforitslifespan.TheVMPshouldpresentanoverviewoftheentirevalidationoperation,itsorganisationalstructure,itscontentandplanning.ThecoreoftheVMPisthelist/inventoryofitemstobevalidatedandtheplanningschedule.TheVMPshouldprovideyourorganisationwiththebasisforvalidationandqualitysystemactivitiesrequiredforcGMPcompliance.Thiswillenableanysterileornon-sterilemedicinalproductthatisproduced,processed,storedordistributed,bythemanufacturingunit,tobevalidatedunderthecontrolofanappropriatequalitysystem.TheVMPshouldprovideacross-referencetootherdocuments,suchasSOP’s,validationprotocols,validationreports,anddesignplans.Arationalefortheinclusionorexclusionofvalidations,fromtheapproachadoptedshouldbeincluded.VMPDocumentTheVMPtemplateisattachedforcompletionasappropriatethedocumentshouldbecross-referencedwithdesignspecifications,designplansandotherrelevantdocumentation.AppendicesshouldcontainalltherelevantdocumentationreferencedorstatedintheVMP.CompanyLogoCompanyNameVALIDATIONMASTERPLANDocumentReference:ReferenceNumberRevision:DraftNumberorRevisionNumberDateofIssue:____/____/____Page:3of___Approvedby:Name:Signature:Date:ProductionTeamLeaderQualityControlOfficerSeniorEngineerCompiledbyTitle:Name:Signature:Date:ValidationEngineerCONTENTS1.0LISTOFABBREVIATIONS.....................................................................................................52.0DOCUMENTREVISIONHISTORY........................................................................................63.0VALIDATIONSTEERINGCOMMITTEE.................................................................................73.1MEMBERSHIPOFVALIDATIONSTEERINGCOMMITTEE................................................................................73.2RESPONSIBILITIES...................................................................................................................................83.2.1PharmacyProductionTeamLeader..............................................................................................................83.2.2PharmacySeniorProductionTechnician..................................................................................