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首页 pi-006-3-recommendation-on-validation-master-pla…

pi-006-3-recommendation-on-validation-master-plan.pdf

pi-006-3-recommendation-on-vali…

shinefzb
2011-10-30 0人阅读 举报 0 0 0 暂无简介

简介:本文档为《pi-006-3-recommendation-on-validation-master-planpdf》,可适用于医药卫生领域

PHARMACEUTICALINSPECTIONCONVENTIONPHARMACEUTICALINSPECTIONCOOPERATIONSCHEMEPISeptemberPISeptemberRECOMMENDATIONSONVALIDATIONMASTERPLANINSTALLATIONANDOPERATIONALQUALIFICATIONNONSTERILEPROCESSVALIDATIONCLEANINGVALIDATION©PICSSeptemberReproductionprohibitedforcommercialpurposesReproductionforinternaluseisauthorised,providedthatthesourceisacknowledgedEditor:PICSSecretariatemail:infopicschemeorgwebsite:http:wwwpicschemeorgPIiSeptemberTABLEOFCONTENTSPageDOCUMENTHISTORYINTRODUCTIONPurposeofthedocumentScopeofthedocumentAimsofQualificationandValidationTerminologyWhentoqualifyandvalidateChangeControlResponsibilityforQualificationandValidationINTERRELATIONSHIPBETWEENQUALIFICATIONANDVALIDATIONVALIDATIONMASTERPLANPrinciplePurposeDefinitionScopeFormatandContentINSTALLATIONANDOPERATIONALQUALIFICATIONPrincipleInstallationQualification(lQ)OverviewStatementInstallationQualificationEssentialElementsOperationalQualification(OQ)OverviewStatementOperationalQualificationEssentialElementsReQualificationQualificationofEstablished(inuse)EquipmentPIiiSeptemberNONSTERILEPROCESSVALIDATIONPrincipleGeneralProspectiveValidationConcurrentValidationRetrospectiveValidationRevalidationChangeControlCLEANINGVALIDATIONPrinciplePurposeandScopeGeneralDocumentationPersonnelEquipmentMicrobiologicalAspectsSamplingDetergentsAnalyticalMethodsEstablishmentofLimitsGLOSSARYREVISIONHISTORYPIPageofSeptemberDOCUMENTHISTORYAdoptionbyPICSCommitteeDecemberEntryintoforceofversionPRMarchEntryintoforceofversionPISeptemberINTRODUCTIONThebasicprinciplesandapplicationofqualificationandvalidationaredescribedinAnnextothePICSandEUGuidetoGMPThisdocumentcomprisesindividualRecommendationsonfourtopicsrelatingtoEquipmentQualificationandProcessValidationinpharmaceuticalmanufacture,asfollows:�ValidationMasterPlan�InstallationandOperationalQualification�NonSterileProcessValidation�CleaningValidationThefourRecommendationscomprisingthisdocumentdefinegeneralprinciplespertainingtoeachofthetopicsPurposeofthedocumentThetopicsoftheseRecommendationdocumentsreflectsomeoftheareasinpharmaceuticalmanufactureidentifiedbybothInspectoratesandthePharmaceuticalIndustryasrequiringguidanceadditionaltothatgiveninthecurrentPICSGMPGuideThepurposeofthisdocumentistoprovideguidanceforGMPinspectorsinreviewingtheissuescoveredtousefortrainingpurposesandinpreparationforinspectionsScopeofthedocumentItisconsideredthattheprinciplesdefinedintheindividualRecommendationdocumentscanbeappliedequallyinthemanufactureofactivepharmaceuticalingredients(APIs)andfinishedpharmaceuticalsAtthetimeofissue,thisdocumentreflectedthecurrentstateoftheartItisnotintendedtobeabarriertotechnicalinnovationorthepursuitofexcellenceTheadviceintheseRecommendationsisnotmandatoryforindustryHowever,industryshouldconsidertheseRecommendationsasappropriateItshouldbenotedthatadditionalrequirementsnotcontainedintheseRecommendationspertaintocomputersystemsimpactingGMPPIPageofSeptemberAimsofQualificationandValidationThequalificationandvalidationprocessshouldestablishandprovidedocumentaryevidencethat:Thepremises,thesupportingutilities,theequipmentandtheprocesseshavebeendesignedinaccordancewiththerequirementsofGMPThisnormallyconstitutesDesignQualificationorDQThepremises,supportingutilitiesandtheequipmenthavebeenbuiltandinstalledincompliancewiththeirdesignspecificationsThisconstitutesInstallationQualificationorIQThepremises,supportingutilitiesandtheequipmentoperateinaccordancewiththeirdesignspecificationsThisconstitutesOperationalQualificationorOQAspecificprocesswillconsistentlyproduceaproductmeetingitspredeterminedspecificationsandqualityattributesThisconstitutesProcessValidationorPVThetermPerformanceQualificationorPQmaybeusedalsoTerminologyTerminologyusedinthefourRecommendationdocumentswhichisnotdefinedinthecurrentglossaryofthePICSGuidetoGMP,ispresentedattheendofthisdocumentItisworthcommentingontheinterchangeabilityoftermstypicallyacceptedinternationallyTheterm‘validation’isoftenassumedtoencompasstheelementsofequipmentqualification,bothInstallationQualificationandOperationalQualification,inadditiontovalidationoftheprocessitselfHowever,forthepurposeoftheseRecommendations,termsarenotusedinterchangeablyWhentoqualifyandvalidateAnyaspectof,includingsignificantchangesto,thepremises,thefacilities,theequipmentortheprocesses,whichmayaffectthequalityoftheproduct,directlyorindirectly,shouldbequalifiedandvalidatedTheconceptofequipmentqualificationisnotanewoneManysuppliershavealwaysperformedequipmentcheckstoconfirmfunctionalityoftheirequipmenttodefinedspecifications,bothpriortoandafterinstallationSimilarly,development,scaleupandtransferintoproductionofproductsandprocessesisnotanewconceptTerminologymaychangeandevendifferbetweenusers,butthebasicconceptsofvalidationareimmutableHowever,documentedrecordsofqualificationandvalidationworkingeneral,havesometimesnotbeengivensufficientconsiderationbyeitherequipmentsuppliersorpharmaceuticalcompaniesinthepastAsaconsequence,companieshavenotalwaysbeenabletoprovidedocumentedevidencetoinspectorsreflectingthetimeandeffortspentincarryingouttheseactivitiesItisimpossibletocategoricallydefinewhatandwhenqualificationandvalidationarenecessary,asmanufacturingoperationsandfacilitiesvaryconsiderablyinsizeandcomplexityPIPageofSeptemberItisarequirementofGMPthateachpharmaceuticalcompanyidentifieswhatqualificationandvalidationworkisrequiredtoprovecontrolofthecriticalaspectsoftheirparticularoperationCommonsenseandanunderstandingofpharmaceuticalprocessinggoalongwaytowardsdeterminingwhataspectsofanoperationarecriticalThekeyelementsofaqualificationandvalidationprogrammeofacompanyshouldbeclearlydefinedanddocumentedinaValidationMasterPlanHighstandardsshouldbestringentlyappliedtodocumentingtheworkprogrammeConsiderableresources,intermsoftime,moneyandpersonnel,aretypicallyrequiredbycompaniestoimplementaqualificationandvalidationprogrammeQualificationandvalidationmaybeaddressedinavarietyofacceptablewaysEachcompanywillhaveapreferredmethodologywhichwillbeconsideredonitsownmeritsbytheInspectorTheexpertiseofsuppliers,contractorsandconsultantsmaybeutilisedforqualificationandvalidationworkInsuchcases,theresponsibilitylieswiththecontractgivertoensurethattherequiredstandardsforthequalityoftheworkwhichiscarriedout,forprogrammecontrolandfordocumentationaremetQualificationandvalidationcannotbeconsideredonceoffexercises,forexample,thestartupofanewmanufacturingoperationAnongoingprogrammeshouldfollowitsfirstimplementationChangeControlCommitmentofthecompanytocontrolchangetopremises,supportingutilities,materials,equipmentandprocessesusedinthemanufactureofmedicinalproductsisessentialtoensureacontinuedvalidationstatusofthesystemsconcernedThiscommitmentshouldbestatedintherelevantcompanydocumentationForexample,theQualityManual,QualityPolicyDocumentsortheValidationMasterPlanAspartofitsQualityManagementSystemthecompanyshouldhaveadefinedandformalisedChangeControlProcedureResponsibilityforQualificationandValidationTheresponsibilityforqualificationandvalidationinpharmaceuticalmanufactureisamultidisciplinaryoneThecurrentPICSGMPGuidestatesthattheheadsoftheProductionandQualityControldepartmentsgenerallyhavetheresponsibility:"Toensurethattheappropriatevalidationsaredone"WhiletheGMPGuidespecificallyidentifiestheresponsibilityoftheProductionandQualityControldepartments,inpractice,otherdepartments,likePICSGMPGuide(v)and(vii)PIPageofSeptemberEngineeringandResearchandDevelopmentaswellasContractorsareusuallyinvolvedintheprogrammeItistheresponsibilityofthepharmaceuticalcompanytodefinetherespectiveresponsibilitiesofitspersonnelandofexternalcontractorsinthequalificationandvalidationprogrammeThisshouldformpartoftheValidationMasterPlanHowever,theQualityAssurancefunctionofacompanyshouldnormallyhaveacriticalroleinoverseeingthewholequalificationandvalidationprocessItisrecommendedthatthevalidationprogrammebeactivelycoordinatedandmanagedbythecompanyTothisend,validationteamsareoftenformedwithspecificrolesidentifiedandassignedtoindividualteammembersItisimperativethatthemostseniorlevelofmanagementwithinthecompanyunderstandsthepersonnel,timeandfinancialresourcesrequiredtoexecuteaqualificationandvalidationprogrammeandcommitsthenecessaryresourcestotheworkINTERRELATIONSHIPBETWEENQUALIFICATIONANDVALIDATIONDesignSpecificationQualificationChangeControlInstallationQualificationOperationalQualificationProcessValidationorPerformanceQualificationPIPageofSeptemberVALIDATIONMASTERPLANPrincipleValidationingeneralrequiresameticulouspreparationandcarefulplanningofthevariousstepsintheprocessInaddition,allworkinvolvedshouldbecarriedoutinastructuredwayaccordingtoformallyauthorisedstandardisedworkingandadministrativeproceduresInadditionvalidationischaracterisedby:�Multidisciplinaryapproach:Aspecificcharacteristicofvalidationworkisthatitrequiresthecollaborationofexpertsofvariousdisciplinessuchaspharmacists,technologists,metrologists,chemicalanalysts,microbiologists,engineers,expertsonQAvalidationetc�Timeconstraints:GenerallyvalidationworkissubmittedtorigoroustimeschedulesThesestudiesarealwaysthelaststagepriortotakingnewprocesses,facilitiesintoroutineoperation�Costs:ValidationstudiesarecostlyastheyrequiretimeofhighlyspecialisedpersonnelandexpensivetechnologyTheabovefactorsrequireawellorganisedandstructuredapproachthatshouldbeadequatelydescribedinaValidationMasterPlan(VMP)PurposeTheVMPshouldpresentanoverviewoftheentirevalidationoperation,itsorganisationalstructure,itscontentandplanningThecoreoftheVMPbeingthelistinventoryoftheitemstobevalidatedandtheplanningscheduleAVMPhelpsmanagement:toknowwhatthevalidationprogrammeinvolveswithrespecttotime,peopleandmoney,andtounderstandthenecessityfortheprogrammeAVMPhelpsallmembersofthevalidationteam:toknowtheirtasksandresponsibilitiesAVMPhelpsGMPinspectors:tounderstandthefirm'sapproachtovalidationandthesetupanorganisationofallvalidationactivitiesDefinitionAValidationMasterPlanisadocumentthatsummarisesthefirm'soverallphilosophy,intentionsandapproachtobeusedforestablishingperformanceadequacyPIPageofSeptemberScopeAllvalidationactivitiesrelatingtocriticaltechnicaloperations,relevanttoproductandprocesscontrolswithinafirmshouldbeincludedinaVMPThisincludesqualificationofcriticalmanufacturingandcontrolequipmentItshouldcompriseallProspective,Concurrent,RetrospectiveValidationsaswellasRevalidationsIncaseoflargeprojectsliketheconstructionofanewfacility,oftenthebestapproachistocreateaseparateVMP(InsuchsituationstheVMPshouldbepartofthetotalprojectmanagement)FormatandContentTheVMPshouldbeasummarydocumentandshouldthereforebebrief,conciseandclearItshouldnotrepeatinformationdocumentedelsewherebutrefertoexistingdocumentssuchasPolicyDocuments,SOP'sandValidationProtocolsReportsTheVMPshouldbeagreedbymanagementAVMPshouldcontaindataonthefollowingsubjectsproposedchaptersIntroductionFirm'svalidationpolicy,generaldescriptionofthescopeofthoseoperationscoveredbytheVMP,locationandschedule(includingpriorities)OrganisationalStructureofAllValidationActivitiesPersonnelresponsibilityfortheVMP,protocolsofindividualvalidationprojects,validationwork,reportanddocumentpreparationandcontrol,approvalauthorisationofvalidationprotocolsandreportsinallstagesofvalidationprocesses,trackingsystemforreferenceandreview,trainingneedsinsupportofvalidationPlantProcessProductDescriptionProvidesacrossreferencetootherdocumentsArationalefortheinclusionorexclusionofvalidations,forthevalidationapproachandtheextentofvalidationshouldbeincludedNote:Acommonprincipleinvalidationstudiesistochallengeprocesses,systemsetcTherationalebehindanychallengeandor“worstcase”PIPageofSeptembersituationshouldbeexplainedConsiderationcanbegiventothegroupingofproductsprocessesforthepurposeofvalidating"worstcase"situationsWhere"worstcase"situationscannotbesimulated,therationaleforthegroupingsmadeshouldbedefinedSpecificProcessConsiderationsUnderthisheadingspecificcharacteristicsrequirementsoftheplantprocessetcthatarecriticalforyieldingaqualityproductandneedextraattentionmaybebrieflyoutlinedhereListofProductsProcessesSystemstobeValidatedAllvalidationactivitiescomprisedintheVMPshouldbesummarisedandcompiledinamatrixformatSuchmatrixshouldprovideanoverviewandcontain:�allitemscoveredbytheVMPthataresubjecttovalidationdescribingtheextentofvalidationrequiredieIQ,OQandorPQItshouldincludevalidationofanalyticaltechniqueswhicharetobeusedindeterminingthevalidationstatusofotherprocessesorsystems,�thevalidationapproach,ieProspective,RetrospectiveorConcurrent,�theRevalidationactivities,�actualstatusandfutureplanningKeyAcceptanceCriteriaGeneralstatementonkeyacceptancecriteriafortheitemslistedunder()aboveDo

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