取样车操作确认方案.doc

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1、XYZFACILITYprotocolpreparationNAMEANDTITLESIGNATUREDATE(mm/dd/yy)PREPAREDBY:QPS,LLCMichaelMolloy,PEConsultantthesignaturesbelowindicateapprovalofthisoperationalprotocol.oncethesignaturesareobtained,executionoftheprotocolmaybegin.protocolapprovalNAMEANDTITLESIGNATUREDATE(mm/dd/yy)APPROVEDBY:XYZEngine

2、eringFacilitiesMangerAPPROVEDBY:XYZProductionProductionManagerAPPROVEDBY:XYZQualityAssuranceQualityAssuranceTABLEOFCONTENTS1.0Purpose32.0Scope33.0EquipmentDescription34.0Responsibilities35.0ReferenceDocuments46.0Definitions47.0MaterialsandEquipment48.0TestFunctionNumberOne:OQSignatureVerificationLis

3、t(Attachment#1)49.0TestFunctionNumberTwo:ProcedureList(Attachment#2)510.0TestFunctionNumberThree:TrainingVerification(Attachment#3)511.0TestFunctionNumberFour:OperatorControlsandIndicators(Attachment#4)512.0TestFunctionNumberFive:FunctionalVerification(Attachment#6)613.0DeviationReportingLog(Attachm

4、ent#10)614.0OperationalQualificationProtocolReview(Attachment#11)715.0SummaryReportRequirements7PurposeTheobjectiveofthisprotocolistoverifythattheRawMaterialsSamplingTentconsistingofthecomponentsdescribedinSection3.0,operateinaccordancetomanufacturers’specifications,andinaccordancewithCurrentGoodMan

5、ufacturingPractices(cGMP’s).·(1)–99”Wx99”Dx110”HSoftwallcleanroom(Model______Serial______)·(2)–23-5/8”Wx47-5/8”Dx13-1/2”HMotorizedHEPAfiltermodules(Model______Serial______)1.0ScopeThisOperationalQualificationProtocolpertainstotheverificationoftheoperationoftheequipmentdescribedinSection3.0ofthisprot

6、ocol,andinstalledintheXYZCOMPANY,ROCKVILLE,MD.ThisprotocolisspecifictotheRawMaterialsSamplingTent,andrelatedinstrumentationandequipment,anddoesnotaddressfacility,orfacilityrelatedequipmentandsystems.2.0EquipmentDescriptionARawMaterialsSamplingTentisprovidedtocreateacontaminant-freeenvironmentofClass

7、10,000forsamplingofincomingmaterials.Thetentis8’Wx8’Lx8’H.Thetentisprovidedwithtwo99.99%ratedHEPAfilterstoprovidethedesiredairflowconditions.Thetentiserectedonan11-gaugetubularsteelframewithwhitebaked