药品生产验证总计划(VMP)

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2019-10-03

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NEWZEALANDHEALTHCAREPHARMACISTS'ASSOCIATIONCompoundingNutrition&OncologySIGPHARMACYMANUFACTURINGUNITVALIDATIONMASTERPLAN(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.NEWZEALANDHEALTHCAREPHARMACISTS'ASSOCIATIONCompoundingNutrition&OncologySIGCompanyLogoCompanyNameVALIDATIONMASTERPLANDocumentReference:ReferenceNumberRevision:DraftNumberorRevisionNumberDateofIssue:____/____/____Page:2of___Approvedby:Name:Signature:Date:ProductionTeamLeaderQualityControlOfficerSeniorEngineerCompiledbyTitle:Name:Signature:Date:ValidationEngineerDoc.Ref.:NZHPACNO-SIGPage:3of____Author:VALIDATIONMASTERPLANDate:Revision01CONTENTS1.0LISTOFABBREVIATIONS..................................................................................................52.0DOCUMENTREVISIONHISTORY......................................................................................63.0VALIDATIONSTEERINGCOMMITTEE...............................................................................73.1MEMBERSHIPOFVALIDATIONSTEERINGCOMMITTEE..................................................................................73.2RESPONSIBILITIES.....................................................................................................................................83.2.1PharmacyProductionTeamLeader.............................................................................................................83.2.2PharmacySeniorProductionTechnician.....................................................................................................83.2.3TrustSeniorEngineer...................................................................................................................................83.2.4PharmacyQualityControlOfficer................................................................................................................83.2.5ValidationEngineer......................................................................................................................................84.0INTRODUCTION..................................................................................................................94.1PURPOSESOFVMP..................................................................................................................................94.2OVERVIEWOFPROJECT............................................................................................................................94.3VALIDATIONPHILOSOPHY..........................................................................................................................95.0REGULATORYSTANDARDSANDGUIDELINES............................................................106.0DESCRIPTIONOFPRODUCTSANDPROCESSES.........................................................116.1INTRODUCTION.......................................................................................................................................116.2PRODUCTGROUPS............................................