设备确认操作规程英文.docx

设备确认操作规程英文.docx

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设备确认操作规程英文

盛年不重来，一日难再晨。

及时宜自勉，岁月不待人。

PURPOSE:

Toprovideaformalmethodologytobefollowedduringqualificationofequipment.

SCOPE:

Applicabletoqualificationofnewequipment,re-qualificationofequipment,whichhasundergonemajormodification,relocationofequipmentandPeriodicQualificationasperscheduleinPharmamanufacturingdepartment.

RESPONSIBILITY:

Production,Engineering,Safety,QualityControlandQualityAssurancestaff.

DEFINITION:

Qualification:

Documentedverificationthattheenvironmentandequipmentareappropriateforthedesignatedfunction.

UserRequirementSpecification（URS）:

ARequirementspecificationthatdescribeswhattheequipmentorsystemissupposetodo,thuscontainingatleastsetofcriteriaorconditionsthathavetobemet.

FunctionalDesignSpecification（FDS）:

Functionaldesignspecificationisadocumentthatspecifiesinacomplete,precise,variablemanner,therequirementdesign,behaviourorothercharacteristicsofasystemorcomponentandoftentheproceduresfordeterminingwhethertheseprovisionshavebeensatisfied.

SpecificationthatisofferedbymanufacturingbasedonURSandareagreedmutually.

DesignQualification（DQ）:

Formalandsystematicverificationthattherequirementsdefinedinthespecificationphasearecompletelycoveredbythesucceedingspecificationorimplementationphase.

FactoryAcceptanceTest（FAT）:

Testingconductedatthesuppliersfactorytodeterminewhetherornotasystemspecifiesit’sacceptancecriteriaandtoenabletheusertodeterminewhetherornottoacceptthesystem.

PREPAREDBYAPPROVEDBYAUTHORISEDBY

DepartmentHeadUnitQualityAssuranceUnitHead

Date:

Date:

Date:

（CQA-56/F3/4）

InstallationQualification（IQ）:

Documentedverificationthatasystemisinstalledaccordingtowrittenandpre-approvedspecifications.

SiteAcceptanceTest（SAT）:

Anacceptancetestattheuserssite,usuallyinvolvethesupplier.

OperationQualification（OQ）:

Documentedverificationthatasystemoperatesaccordingtowrittenandpre-approvedspecificationthroughoutallspecifiedoperatingranges.

PLCValidation:

DocumentedverificationthatPLCHardwareareasperoriginaldrawing,DigitalandAnalogInputandOutputareconnectedasperPLCArchitectureandfunctioningaccordingtowrittenandpre-approvedspecificationthroughoutallspecifiedoperatingranges.

PerformanceQualification（PQ）:

Documentedverificationthatasystemiscapableofperformingorcontrollingtheactivitiesoftheprocesses,itisrequiredtoperformorcontrol,accordingtowrittenandpre-approvedspecifications,whileoperatinginitsspecifiedoperatingenvironment.

User（s）:

Theperson,orpersons,whooperateorinteractdirectlywiththesystem.

Supplier:

Anyorganisationorindividualcontacteddirectlybytheusertosupplyaproductorservice.

CriticalEquipment:

Themachinewithinasystemwherethemalfunctioningorfailureofequipmentwillhavedirectimpactonproductquality.Whereproductisindirectcontactwithmachinebodyparts.

Non-criticalEquipment:

Themachinewithinasystemwherethemalfunctioningorfailureofequipmentwillnothavedirectimpactonproductquality.Whereproductisnotindirectcontactwithmachinebodyparts.

1.0HEALTH,SAFETYANDENVIRONMENT:

（对验证实施人员的HES要求）

1.1Personnelinvolvedinqualification/re-qualification/periodicqualificationshoulduseappropriatepersonalprotectiveequipment.

1.2Donottouchthemovingparts.

1.3Electricalisolationshouldbedonebeforeanyelectriccontrolpanelverification.

1.4ReadthesafetyinstructionsspecifiedintheoperationManualofthemachinetobequalified.

2.0PROCEDURE:

2.1Equipmentqualificationshouldbebasedonthefollowingdocuments

2.1.1UserRequirementSpecification（URS）

2.1.2FunctionalDesignSpecification（FDS）

2.1.3DesignQualification（DQ）

2.1.4FactoryAcceptanceTest（FAT）

2.1.5ChecklistonReceipt

2.1.6InstallationQualification（IQ）

2.1.7OperationQualification（OQ）

2.1.8PLCValidation（Ifapplicable）

2.1.9ProvisionalHandoverCertificate

2.1.10PerformanceQualification（PQ）

2.1.11HandoverCertificate

Theflowoftheequipmentqualificationisasfollows

URSFDSDQFATIQOQPLCValidation（ifapplicable）SATPQ

2.1.1UserRequirementSpecification（URS）:

2.1.1.1URSprotocolshouldbeapprovedbytheprojectteam（Users）membersandQualityAssurancewithName,SignandDate.

2.1.1.2FollowingpointsshouldbeconsideredduringthedevelopmentofURS.

ØIntroduction

ØOverview

ØOperationrequirements

ØConstraints

ØLifecycle

ØGlossary

ØReferences

ØApproval

2.1.1.3EachURSprotocolshouldbeallottedwithaprotocolno.intheformatspecifiedbelow

“URS/P”

Where,

“URS”standsforUserrequirementspecification.

“P”standsforequipment/instrument/balance/areaabbreviatedcode.

2.1.1.4TheprotocolshouldalsoidentifywithaVersionNo.Wheretheversionno.changeswitheverychangeintheURS.

2.1.1.5TheURSprotocolheadershouldconsistofthefollowingdetailsasmentionedbelow:

ØTitleoftheURS

ØProtocolNo.

ØVersionNo.

ØDate

ØCiplaPatalganga

ØUnit

ØPageNo.

Aspecimenoftheheaderisgivenbelow:

ProtocolNo.:

URS/P

TITLE

CiplaPatalganga

VersionNo.:

Unit:

Date:

Pagexofy

2.1.2FunctionalDesignSpecification（FDS）:

2.1.2.1TheFDSshouldbethemanufacturerinterpretationofURS.FDSshouldincludebasicfunctioningoftheequipmentwithfocusoncontrolandcriticalcomponentsspecificationsandfunctions.

2.1.2.2TheFDSshouldbeintheformofseparatedocumentandshouldincludeequipmentspecification,P&IDdiagrams.

2.1.2.3TheFDSprotocol/reportshouldbemutuallyapprovedbytheuserandsupplierwithsufficienttechnicaldetailsbasedonthetechnocommercialoffer.

2.1.2.4ThesupplierisfinallyselectedandCERisraised.

2.1.2.5AnychangesmadeafterfinalisationofDQshouldundergochangecontrolprocedureasperSOPCQA06.

2.1.3DesignQualification（DQ）:

2.1.3.1DesignqualificationshouldbebasedonthediscussionbetweenthesupplierandtheuserwithreferencetoURS/FDS.

2.1.3.2Followingpointsshouldbeconsideredduringthedevelopmentofdesignqualification.

ØPurpose

ØScope

ØResponsibility

ØProjectrequirement

ØCriticalvariablestobemet

ØProcess/Productparameterse.g.Capacityetc.

ØcGMPconsiderations

e.g.MOCofindividualparts,finishofcontactparts

ØCriticalparameterse.g.Instrumentation,limits,

ØSafety

ØLocationsuitability

ØReferences

ØDocumentstobeattached.

ØAnychangesmadeagainsttheformallyagreedparameters（Deviationifany）.

ØJustificationforacceptance（ifanydeviation）

ØReview（Inclusiveoffollowupaction,ifany）

ØRecommendation

ØSigningoff

2.1.3.3AnychangeinDQshouldbethroughachangecontrolprocedureasperSOPCQA-06andshouldbedocumented.

2.1.4FactoryAcceptanceTest（FAT）:

2.4.1TheFATshouldbeconductedatthesupplier’spremisesundertheuserssupervisionunlessagreedupon.

2.4.2TheFATprotocol/reportshouldbepreparedbythesupplierasperManufacturersformatandshouldbesubmittedforapprovalofuser.

2.4.3Theequipmentshouldbeshippedtothesiteonlyafterapprovalbytheuser.

2.4.4TheFATprotocol/reportshouldincludedetailsoftheURSandFDS.

2.4.5Anymodification,changesneedsduringtheFATshouldbedocumentedandintimatedtotheuserandcarriedoutwithmutualconsent.

2.1.5ChecklistonReceipt:

2.1.5.1Allcriticalpartsofequipmentshouldbecheckedforfinish,anydamagesonreceiptforavailabilityasperpackinglistandorderdetails.

2.1.6InstallationQualification（IQ）:

2.1.6.1Allaspectssuchasutilityconnections,locationsuitability,materialofconstructionofcriticalparts,installationofallmonitoring,controlling,instrumentsandgaugesincludingtheircalibrationandcertificationbysuppliershouldbecheckedandverified.

2.1.6.2DuringtheinstallationqualificationAreaLuxlevel,Floordrains,pipingconnections,machinealignment,levelling,P&IDDiagram,Schematic,circuitdiagram,tagging,wiringpheruling,pneumaticconnectionsconsideredduringdesignqualificationarecheckedandverified.

2.1.7OperationQualification（OQ）:

2.1.7.1DuringOperationqualificationtheworkingofthemonitoringandcontrollinginstruments,gaugesandsystemslikePLC,switches,gauges,motors,pumpsetc.arecheckedandcertified.

2.1.7.2Theparametersconsideredduringdesignqualificationarecheckedandcertified.

2.1.8PLCValidation

2.1.8.1PLCvalidationshouldbecarriedoutbycompetentexternalapprovedagency.

2.1.8.2PLCvalidationshouldbecarriedoutduringSATorsubsequentlywithinthreemonthsbasedonlevelofcheckscarriedoutduringSAT.Validationshouldbedoneaccordingtopre-approvedprotocolandreport.Allreferenceinstrumentsbeingusedforvalidationshouldbecertifiedbyapprovedagencieslike‘IDEMI’and‘ERTL.

2.1.8.3Briefdescriptionaboutequipmentoperatingfunctionanditslocationshouldbementionedinthereport.Allrawdatashouldbehandwrittenatsiteduringactualvalidation.

2.1.8.4ThedetailsofPLCandHMIhardwarearecheckedaspercircuitdiagramandtypeofPLC,HMI,itssoftwareVersionno.details,detailsoftheavailabledigital/analogueinputsandoutputs.Installedswitchgeardetailsshouldbementionedi.e.SFU,MCB,relays,contactors,pushbuttons,switch,powersupply,Surgeprotectionetc.

2.1.8.5Equipmentinterlocks,alarmsandoperationlogicshouldbechecked.DetailsofthePLCBatteryconditionsshouldbecheckedandit’slifewillbeverifiedappropriately.

2.1.8.6AllPLCvalidationreportsshouldbehandedoverbyth