取样车操作确认方案

DOCNo.:__________OPERATIONALQUALIFICATION(OQ)PROTOCOLProject#:OPERATIONALQUALIFICATIONOFTHERAWMATERIALSSAMPLINGTENTEQUIPMENT(_________)ATXYZCOMPANYROCKVILLE,MDXYZFACILITYPROTOCOLPREPARATIONNAMEANDTITLESIGNATUREDATE(mm/dd/yy)PREPAREDBY:QPS,LLCMichaelMolloy,PEConsultantTHESIGNATURESBELOWINDICATEAPPROVALOFTHISOPERATIONALPROTOCOL.ONCETHESIGNATURESAREOBTAINED,EXECUTIONOFTHEPROTOCOLMAYBEGIN.PROTOCOLAPPROVALNAMEANDTITLESIGNATUREDATE(mm/dd/yy)APPROVEDBY:XYZEngineeringFacilitiesMangerAPPROVEDBY:XYZProductionProductionManagerAPPROVEDBY:XYZQualityAssuranceQualityAssuranceDOCNo.:__________OPERATIONALQUALIFICATION(OQ)PROTOCOLProject#:OPERATIONALQUALIFICATIONOFTHERAWMATERIALSSAMPLINGTENTEQUIPMENT(_________)ATXYZCOMPANYROCKVILLE,MDPage2of15TABLEOFCONTENTS1.0Purpose.............................................................................................................................................32.0Scope................................................................................................................................................33.0EquipmentDescription....................................................................................................................34.0Responsibilities................................................................................................................................35.0ReferenceDocuments......................................................................................................................46.0Definitions........................................................................................................................................47.0MaterialsandEquipment.................................................................................................................48.0TestFunctionNumberOne:OQSignatureVerificationList(Attachment#1)..............................49.0TestFunctionNumberTwo:ProcedureList(Attachment#2).......................................................510.0TestFunctionNumberThree:TrainingVerification(Attachment#3)...........................................511.0TestFunctionNumberFour:OperatorControlsandIndicators(Attachment#4)..........................512.0TestFunctionNumberFive:FunctionalVerification(Attachment#6)..........................................613.0DeviationReportingLog(Attachment#10)....................................................................................614.0OperationalQualificationProtocolReview(Attachment#11)........................................................715.0SummaryReportRequirements.......................................................................................................7DOCNo.:__________OPERATIONALQUALIFICATION(OQ)PROTOCOLProject#:OPERATIONALQUALIFICATIONOFTHERAWMATERIALSSAMPLINGTENTEQUIPMENT(_________)ATXYZCOMPANYROCKVILLE,MDPage3of151.0PurposeTheobjectiveofthisprotocolistoverifythattheRawMaterialsSamplingTentconsistingofthecomponentsdescribedinSection3.0,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______)2.0ScopeThisOperationalQualificationProtocolpertainstotheverificationoftheoperationoftheequipmentdescribedinSection3.0ofthisprotocol,andinstalledintheXYZCOMPANY,ROCKVILLE,MD.ThisprotocolisspecifictotheRawMaterialsSamplingTent,andrelatedinstrumentationandequipment,anddoesnotaddressfacility,orfacilityrelatedequipmentandsystems.3.0EquipmentDescriptionARawMaterialsSamplingTentisprovidedtocreateacontaminant-freeenvironmentofClass10,000forsamplingofincomingmaterials.Thetentis8’Wx8’Lx8’H.Thetentisprovidedwithtwo99.99%ratedHEPAfilterstoprovidethedesiredairflowconditions.Thetentiserectedonan11-gaugetubularsteelframewithwhitebaked-enamelfinish.Ithas20-milthickclearvinylwallsthatoverlapeachotherby6”forentryandexit.Two120-VACrecessedlightfixtureswithfourF40T12fluorescentlightbulbsareprovided.Thereisa12”clearancebetweenthebottomofthevinylwallsandthefloor.4.0Responsibilities4.1QualificationProcessSolutions,LLC(QPS)4.1.1ItistheresponsibilityofQPStowriteandexecutethisOperationalQualificationprotocol.4.1.2ItistheresponsibilityofQPStowriteafinalreportthatincludesasummaryofworkperformed,anyexceptionsnotedduringtheexecutionoftheprotocol,andconclusionsderivedfromthedatagathered.4.2XYZCOMPANY4.2.1Followingtheexecution,XYZ’sQualityAssuranceDepartmentwillrevieweachattachmentpagetoverifythatthedatahavebeencompletelyandaccuratelyrecorded.4.2.2XYZ’sEngineeringDepartmentisresponsibletoprovideallnecessarydocumentation,includingSiteAcceptanceTests,ifapplicable,forthegeneration,execution,andcompletionofprotocols,andcompletionoffinalreports.4.2.3XYZisresponsibleforthereviewandapprovalofthisprotocolandrelateddocumentationtoassurecompliancewithXYZ’sstandardoperatingproceduresdesignedtosupporttheFACILITY,andtoverifythattherelevantXYZstandardsfortheFACILITYaremet.DOCNo.:__________OPERATIONALQUALIFICA