取样车操作确认方案

DOCNo.:__________OPERATIONALQUALIFICATION(OQ)PROTOCOLProject#:OPERATIONALQUALIFICATIONOFTHERAWMATERIALSSAMPLINGTENTEQUIPMENT(_________)ATXYZCOMPANYROCKVILLE XYZFACILITYprotocolpreparationNAMEANDTITLESIGNATUREDATE(mm/dd/yy)PREPAREDBY:QPS,LLCMichaelMolloy,PEConsultantthesignaturesbelowindicateapprovalofthisoperationalprotocol.oncethesignaturesareobtained,executionoftheprotocolmaytocolapprovalNAMEANDTITLESIGNATUREDATE(mm/dd/yy)APPROVEDBY:XYZEngineeringFacilitiesMangerAPPROVEDBY:XYZProductionProductionManagerAPPROVEDBY:XYZQualityAssuranceQualityAssuranceDOCNo.:__________OPERATIONALQUALIFICATION(OQ)PROTOCOLProject#:OPERATIONALQUALIFICATIONOFTHERAWMATERIALSSAMPLINGTENTEQUIPMENT(_________)ATXYZCOMPANYROCKVILLEPagePAGE15ofNUMPAGES15TABLEOFCONTENTSTOC\o"3-3"\h\z1.0 Purpose 32.0 Scope 33.0 EquipmentDescription 34.0 Responsibilities 35.0 ReferenceDocuments 46.0 Definitions 47.0 MaterialsandEquipment 48.0 TestFunctionNumberOne:OQSignatureVerificationList(Attachment#1) 49.0 TestFunctionNumberTwo:ProcedureList(Attachment#2) 510.0 TestFunctionNumberThree:TrainingVerification(Attachment#3) 511.0 TestFunctionNumberFour:OperatorControlsandIndicators(Attachment#4) 512.0 TestFunctionNumberFive:FunctionalVerification(Attachment#6) 613.0 DeviationReportingLog(Attachment#10) 614.0 OperationalQualificationProtocolReview(Attachment#11) 715.0 SummaryReportRequirements 7

PurposeTheobjectiveofthisprotocolistoverifythattheRawMaterialsSamplingTentconsistingofthecomponentsdescribedinSection3.0,operateinaccordancetomanufacturers’specifications,andinaccordancewithCurrentGoodManufacturingPractices(cGMP’s).(1)–99”Wx99”Dx110”HSoftwallcleanroom(Model______Serial______)(2)–23-5/8”Wx47-5/8”Dx13-1/2”HMotorizedHEPAfiltermodules(Model______Serial______)ScopeThisOperationalQualificationProtocolpertainstotheverificationoftheoperationoftheequipmentdescribedinSection3.0ofthisprotocol,andinstalledintheXYZCOMPANY,ROCKVILLE,EquipmentDescriptionARawMaterialsSamplingTentisprovidedtocreateacontaminant-freeenvironmentofClass10,000forsamplingofincomingmaterials.Thetentis8’Wx8’Lx8’H.Thetentisprovidedwithtwo99.99%ratedHEPAfilterstoprovidethedesiredairflowconditions.Thetentiserectedonan11-gaugetubularsteelframewithwhitebaked-enamelfinish.Ithas20-milthickclearvinylwallsthatoverlapeachotherby6”forentryandexit.Two120-VACrecessedlightfixtureswithfourF40T12fluorescentlightbulbsareprovided.Thereisa12”clearancebetweenthebottomofthevinylwallsandthefloor.ResponsibilitiesQualificationProcessSolutions,LLC(QPS)ItistheresponsibilityofQPStowriteandexecutethisOperationalQualificationprotocol.ItistheresponsibilityofQPStowriteafinalreportthatincludesasummaryofworkperformed,anyexceptionsnotedduringtheexecutionoftheprotocol,andconclusionsderivedfromthedatagathered.XYZCOMPANYFollowingtheexecution,XYZ’sQualityAssuranceDepartmentwillrevieweachattachmentpagetoverifythatthedatahavebeencompletelyandaccuratelyrecorded.XYZ’sEngineeringDepartmentisresponsibletoprovideallnecessarydocumentation,includingSiteAcceptanceTests,ifapplicable,forthegeneration,execution,andcompletionofprotocols,andcompletionoffinalreports.XYZisresponsibleforthereviewandapprovalofthisprotocolandrelateddocumentationtoassurecompliancewithXYZ’sstandardoperatingproceduresdesignedtosupporttheFACILITY,andtoverifythattherelevantXYZstandardsfortheFACILITYaremet.XYZEngineeringisresponsibleforthereviewandapprovalofthisprotocolandrelateddocumentationandtoassurethatinstallationandoperationareasspecified.XYZQualityAssuranceisresponsibleforthereviewandapprovalofthisprotocolandthefinalsummaryreport.ReferenceDocumentsXYZSOPNo.:DocumentControlXYZSOPNo.:StandardOperatingProceduresXYZSOPNo.:StandardOperatingProcedureRevisionRequestXYZSOPNo.:DeviationControlOperationsManualPurchaseOrderSpecificationsDraftOperationalSOPsDraftCleaningSOPsDraftMaintenanceSOPsDefinitionsCriticalInstrumentation–Criticalinstrumentsaredefinedasthosewhoseperformancewillaffecttheoperationofthesystemand/orthequalityattributesoftheprocessedmaterials.CriticalinstrumentsarecalibratedandcertifiedusingstandardsthataretraceabletoNIST(NationalInstitutesofStandardsandTesting).Non-CriticalInstrumentation–Instrumentationprovidedforindicationorconveniencepurposesonly.Deviation–Anyevent(plannedorunplanned)thathasthepotentialtoadverselyimpactproductquality.Deviationsmayormaynothavethepotentialtoimpactoperationsandoperationalcosts.Variance–Anyevent(plannedorunplanned)thathasthepotentialtoimpactoperationsandoperationscostsandnoimpactonproductquality.CorrectiveAction–ACorrectiveActionRequest(CAR)shallbesubmittedintheeventofnon-conformity.Non-conformityisconsideredafailureinXYZ’squalitysystem.MaterialsandEquipmentListallspecificmaterialsandequipmentneededforprotocolexecution.TestFunctionNumberOne:OQSignatureVerificationList(Attachment#1)ObjectiveToidentifyanddocumentallpersonnelinvolvedinexecutingthisprotocol.FrequencyThistestwillbeperformeduponthecompletionofthisqualificationprotocol.Thereisnorequirementforrepeattestingunlesstheequipmentismodified.ProcedureVerifythateachpersonwhoexecutesthisprotocolsignsAttachment#1.Eachpersonmustbeidentifiedbyname,title,company,signature,initialsanddateontheattachedform.AcceptanceCriteriaSignaturesfromallpersonnelinvolvedinexecutionofthisprotocolshallbepresent.TestFunctionNumberTwo:ProcedureList(Attachment#2)ObjectiveToverifytheoperatingStandardOperatingProcedures(SOP’s)provideadequatedirectionandcontrolovertheoperationoftheequipment.FrequencyThistestwillbeperformeduponthecompletionofthisqualificationprotocol.Thereisnorequirementforrepeattestingunlesstheequipmentismodified.ProcedureVerifythattheoperationalSOPprovidespersonneladequatedirectionandcontrolovertheoperationoftheequipment.(TheSOP’susedforexecutionmaybeindraftform.)CompletetheapplicableattachmentwithalistofallapplicableSOP’s.RedlinetheSOP’swithanoperatorandvalidationpersonnel.Attachtheredlinecopytothisqualificationprotocol.AcceptanceCriteriaAllassociatedSOP’sforoperationandexecutionshallbereviewedanddocumented.TestFunctionNumberThree:TrainingVerification(Attachment#3)ObjectiveTodocumentapplicablepersonnelhavereceivedtherequiredtrainingforoperationoftheequipment.FrequencyThistestwillbeperformeduponthecompletionofthisqualificationprotocol.Thereisnorequirementforrepeattestingunlesstheequipmentismodified.ProcedureDocumentallpersonnelexecutingthisprotocolthathavebeentrainedontheapproved/draftSOPfortheequipment.ListallSOP’susedduringtheexecutionofthisprotocolCompleterequiredtrainingformsinXYZTrainingProgram.AcceptanceCriteriaTrainingshallbeperformedonallSOP’susedduringtheexecutionofthisqualificationprotocol.TestFunctionNumberFour:OperatorControlsandIndicators(Attachment#4)ObjectiveToverifythecontrolsandindicatorsoperateasspecifiedbymanufacturerrecommendations.FrequencyThistestwillbeperformeduponthecompletionofthisqualificationprotocol.Thereisnorequirementforrepeattestingunlesstheequipmentismodified.ProcedureManuallyoperatethecontrolswitcheslistedintheapplicableattachment.Visuallyverifyanddocumenttheactualresponses.DocumentanydiscrepanciesinAttachment#10,DeviationReportingLog.Ifanyvariances/deviationsarepresent,completetheappropriatedeviation/varianceformasperXYZSOPNo.:_____.AcceptanceCriteriaAlloperatorcontrolsandindicatorstestedshallconformtotheexpectedresponse.TestFunctionNumberFive:FunctionalVerification(Attachment#6)ObjectiveToverifyanddocumenttheoperationandfunctionalityoftheequipment.FrequencyThistestwillbeperformeduponthecompletionofthisqualificationprotocol.Thereisnorequirementforrepeattestingunlesstheequipmentismodified.ProcedureFollowtheproceduresintheapplicableattachments.Visuallyverifyanddocumenttheactualresponsesaspassorfailagainsttheexpectedresults.DocumentallparametersusedduringexecutioninAttachment#7DocumentanydiscrepanciesinAttachment#10,DeviationReportingLog.Ifanyvariances/deviationsarepresent,completetheappropriatedeviation/varianceformasperXYZSOPNo.:_____.AcceptanceCriteriaAllfunctionalrequirementsmustconformtotheexpectedresponses.DeviationReportingLog(Attachment#10)ObjectiveTodocumentanydeviationtothestatedtestprocedureoracceptancecriteria,andtoevaluatethedeviationrelativetoacceptabilityofthequalificationstudy.FrequencyAlldeviationswillbeaddressedperthissection,priortofinalapprovalofthequalificationprotocol.ProcedureDocumentalldeviationsfoundduringexecution.CompletetheDeviation/VarianceFormasperXYZSOPNo.:_____,immediatelyuponanyobserveddeviations.RoutethedeviationformforreviewandapprovalfromQualityAssurance(QA),priortofinalapprovalofthisprotocol.IfrequiredbyQA,obtainandcompleteaCorrectiveActionRequest(CAR)FormperCorrectiveActionSystem.AcceptanceCriteriaAlldeviationsshallbepropertydocumentedontheDeviation/VarianceForm.Alldeviationreportsandcorrectiveactionforms,ifnecessary,shallbeapprovedpriortofinalapprovalofthisqualificationprotocol.

OperationalQualificationProtocolReview(Attachment#11)ObjectiveTodocumentthatthisprotocolhasbeenreviewedforcompletenessasperXYZCOMPANYrequirements.FrequencyThistestwillbeperformeduponexecutioncompletionofthisoperationalqualificationprotocol.Thereisnorequirementforrepeattestingunlesstheequipmentismodified.ProcedureCompleteattachmentwithname,title,signatureanddate.SummaryReportRequirementsObjectiveToprovideanoverviewofthetestresultsduringtheexecutionofthisoperationalqualification.FrequencyThissummaryreportwillbegeneratedonthecompletionoftheoperationalqualification.ProcedureGenerateafinalsummaryoncompletionofthisprotocolexecution.Compileasummaryoftheresultsobtained.Generateaconclusion,basedontheseresults,oftheacceptabilityofthequalificationresults.Includeastatementofconformancetothespecifiedacceptancecriteria,evaluatedinconjunctionwiththeapproveddeviationsandcorrectiveactionstaken.Determinationofacceptabilityoftheprotocol,asexecuted.Attachthecompleted,executedandapprovedprotocoltothefinalreport.Attachedcopiesofallcompleted,approvedDeviationReportandCorrectiveActionForms,wherenecessary.AttachmentListTOC\o"3-3"\h\zAttachment#1OQSignatureVerificationList 8Attachment#2ProcedureList 9Attachment#3TrainingVerification 10Attachment#4OperatorControlsandIndicators 11Attachment#6FunctionalVerification 12Attachment#6FunctionalVerification 13Attachment#10DeviationReportingLog 14Attachment#11OperationalQualificationProtocolReview 15

Attachment#1OQSignatureVerificationListThissectionidentifiesthepersonnelconductingtheOperationalQualification.Eachpersonwhowillbeexecutingthisprotocolshallcompleteanentryonthepage.PrintNameTitleDepartment/CompanyNameSignatureInitialsDateComments:______________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________AcceptanceCriteria:Signaturesfromallpersonnelinvolvedinexecutionofthisprotocolshallbepresent.MeetsAcceptanceCriteria?()Yes()NoReviewedby:__________________________________ Date:__________

Attachment#2ProcedureListListtheStandardOperatingProcedures(SOP)thatarerequiredforexecutionofthisprotocol.SOPNumberSOPRevision#ProcedureTitleEffectiveDateInitials/DateCleaningoftheRawMaterialsSamplingTentOperationoftheRawMaterialsSamplingTentMaintenanceoftheRawMaterialsSamplingTentComments:______________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________AcceptanceCriteria:Alistofwrittenproceduresthatareusedtooperatetheequipmentisprovidedabove.Ifproceduresareindraftform,attachacopytotheexecutedprotocol.MeetsAcceptanceCriteria?()Yes()NoReviewedby:__________________________________ Date:__________

Attachment#3TrainingVerificationListtheStandardOperatingProcedures(SOP)usedtotrainpersonnelforoperatingtheequipment.SOP#ProcedureTitleTrainingDocumented(Y/N)Initials/DateCleaningoftheRawMaterialsSamplingTentYes/NoOperationoftheRawMaterialsSamplingTentYes/NoMaintenanceoftheRawMaterialsSamplingTentYes/NoComments:______________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________AcceptanceCriteria:Alistofwrittenproceduresthatareusedtotrainpersonneltooperatetheequipmentisprovidedabove.MeetsAcceptanceCriteria?()Yes()NoReviewedby:__________________________________ Date:__________

Attachment#4OperatorControlsandIndicatorsPressthecontrolkeystoverifythattheequipment/systemoperationsfunctionasindicated.Note:documentanyfailingresults.ControlFunctionExpectedResultsPass/FailInitials/DateMainPowerMoveswitchtoONpositionLightscomeonfansstartPass/FailMainPowerOFFMoveswitchtoOFFpositionLightsturnofffansstopPass/FailHEPA#1-SpeedPot(LOW)MovePottoLOWFanrotatesslowlyornotatallPass/FailHEPA#1-SpeedPot(HIGH)MovePottoHIGHFanrotatesatafasterspeedPass/FailHEPA#2-SpeedPot(LOW)MovePottoLOWFanrotatesslowlyornotatallPass/FailHEPA#2-SpeedPot(HIGH)MovePottoHIGHFanrotatesatafasterspeedPass/FailComments:______________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________AcceptanceCriteria:Theactualresultsarethesameastheexpectedresultsorexplained.MeetsAcceptanceCriteria?()Yes()NoReviewedby:__________________________________ Date:__________

Attachment#6FunctionalVerificationVerifythattheequipment/systemoperationsfunctionasindicated.ProcedureExpectedResultsPass/FailInitials/DateFaceVelocityTest:HEPA#1-Turnonmainpower,turnoncontrolboxpower,setspeedtodeliver72-108fpm.Measureairflowusingcalibrateddevice.Equipmentpowersup,fansstart,HEPAdelivers72-108fpm.Speedsetting:__________Airflow:____________Pass/FailFaceVelocityTest:HEPA#2-Turnonmainpower,turnoncontrolboxpower,setspeedtodeliver72-108fpm.Measureairflowusingcalibrateddevice.Equipmentpowersup,fansstart,HEPAdelivers72-108fpm.Speedsetting:__________Airflow:____________Pass/FailStaticParticulateTest:Measureroomparticulatesattheworksurfaceusingacalibratedmeter.Measureingridwithintentworkarea(minimum8samplepoints).Particulatecountlessthan10,000-0.5micronparticles.0.5MicronAverageCount:________________Particulatecountlessthan56-5micronparticles.5MicronAverageCount:________________Pass/FailPressurization:Measurethedifferentialpressurefromtheinsideofthetenttotheoutsideusingacalibratedmeter.Differentialpressureispositivefrominsideoftenttooutside.AveragePressure:_______Pass/FailComments:____________________________________________________________________________________________________________________________________________________________________________________________________________________________________________AcceptanceCriteria:Theactualresultsarethesameastheexpectedresultsorexplained. MeetsAcceptanceCriteria?()Yes()NoReviewedby:__________________________________ Date:__________

Attachment#6FunctionalVerificationVerifythattheequipment/systemoperationsfunctionasindicated.ProcedureExpectedResultsPass/FailInitials/DateDynamicParticulateTest:Setuptentforrawmaterialsamplingprocess.Setupparticlecounter,startcounter.FollowingoperationsSOPsimulatesamplingprocess.Particulatecountlessthan100,000-0.5micronparticles.0.5MicronAverageCount:________________Particulatecountlessthan566-5micronparticles.5MicronAverageCou