3/1/2017 GMPMANUAL

6.FOperationalqualification(OQ)
Up04UlrikeReuter,MaxLazar

Hereyouwillfindanswerstothefollowingquestions:
WhatisunderstoodbythetermOQ?
WhattestsarecarriedoutduringOQ?
WhatdocumentsarecompiledduringOQ?

Figure6.F1DefinitionofOQ

DefinitionofOQ(EUGMPGuideline,Annex15)

Operationalqualification(OQ)
Thedocumentedverificationthatthefacilities,systemsandequipment,asinstalledormodified,performasintended
throughouttheanticipatedoperatingranges.

Operationalqualificationensuresthattheequipmentworksasplannedandthatitsproperfunctionisguaranteedacrossthe
entirerangeofprocesscriticalparameters.Operationalqualificationbeginsaftersuccessfulcompletionofinstallation
qualification.

Tocheckthepredeterminedfunctionalityofallcomponentsoftheequipment,testproceduresaredevelopedand
correspondingacceptancecriteriaaredefinedinadvance.Theessentialelementsofoperationalqualificationare
summarizedinFigure6.F2.

Figure6.F2Typicalelementsofoperationalqualification

Typicalelementsofoperationalqualification

Executionanddocumentationofthecalibrationofqualityrelevantmeasuringpoints(initialcalibration)anddefinitionof
thecalibrationintervals
Checkingofelectromagneticcompatibility
Identificationandcheckingofthefunctionsthatinfluencequality(riskanalysis)includingverificationoftheperformance
parametersprescribedinaccordancewithDQ
Identificationandcheckingofthecontrolofsafetydevices,alarmsandfailuremessages(riskanalysis)
CEconformityormanufacturer'sdeclaration
Verificationoftheenvironmentalconditions
Compilationofoperatingproceduresforoperatingtheequipment,basedontheoperatingmanual
Checkingand,ifrelevant,adaptationofoperatingproceduresforcalibrationandservicingoftheequipment
Creationofalogbook
Checkingand,ifnecessary,adaptationofoperatingproceduresforthecleaningordisinfection/sterilizationofthe
equipment

Thefollowingrequirementsfortheexecutionofthefunctiontestsareconsideredtobeindispensable:
Completionofinitialcalibration:thequalityrelevantmeasuringpointsmustbecalibrated.
Useofcalibratedtestequipment:ItmustbepossibletotracetheequipmentusedfortestsduringtheOQtoanaccepted
norm.
Completionoftestingforelectromagneticcompatibility(EMC)

Possibleoperatingconstraints,suchasthecontainmentoftheoriginallyintendedworkingarea,whichresultfromthe
qualification,mustbelistedintheoperatingprocedure.Atleastadraftformoftheoperatingproceduresmustbeavailable
foroperationalqualificationanduponcompletionofthisqualificationphasetheyshouldenterintoforce.Theoperating
procedurethenbecomesarequirementforstafftrainingandthusultimatelybecomesthebasisforqualifiedoperationofa
qualifiedpieceofequipment.

Operationalqualificationisnotusuallyproductspecific,i.e.itextendsacrosstheentirerange(workingarea)ofthedifferent
functionsoftheequipment.Inadditiontotheworkingarea,ancillaryconditionsshouldalsobetestedhere(e.g.therestart
behaviorafterswitchingtheequipmentoff).

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Inprinciple,itisrecommendedthatallqualificationactivitiesbeaccompaniedbydeviationlists.Ifdeviationsoccur,they
arerecordedinthelistandatimebywhichtheyshouldbeeliminatedandthepersonresponsiblefordoingsoisdefined.
Qualificationactivitiesarethenresumeddependingonthesignificanceofthedeviationthatoccurred,orareinterruptedand
onlycontinuedoncethedeviationhasbeeneliminated.

Successfulexecutionoftheinstallationandoperationalqualificationrepresentstheprerequisitefortechnicalacceptanceof
theequipmentandshouldbecarriedoutasclosetogetheraspossible.

6.F.1ExamplesofOQplans
ThegeneralrequirementsofthequalificationdocumentationaredescribedinChapterD.7.Therearenumerouswaysof
structuringtheindividualdocuments.Apossiblesystematicprocedureispresentedinthischapter.Theformsmaybeused
asatemplateforfillingwiththefacilityspecifictestpoints.Thedocumentsarestructuredsothatthequalificationplan(list
ofthetestpointswithacceptancecriteria)andthetestprotocol(documentationofthetestcarriedout)aresummarizedina
singledocument.

Thefollowingformsareincluded:
OQtestprotocolSafetydevices
OQtestprotocolRiskanalysisOperatingfunctions
OQqualificationreport
QualificationplanTestprotocolOQ3:
Verificationofthecheckforthepresenceofscrewcaps

6.F.1.1Safetydevices

Figure6.F3OQtestprotocol1

OQqualificationplan
OQtestprotocol1:
Company Safetydevices Pagexv.y

Qualificationplanforfacilitiesandequipmentforpharmaceuticalproductsat validfrom
QP08154721 theIxbergsite 01.10.2003

Qualificationproject
no. Facility/equipment Inventoryno.

Recordcompiled
(Date/signature)

Recordapprovedforimplementation
(Date/signature)

Testcarriedout
(Date/signature)

Testresultapproved
(Date/signature)

1. Scope

Thistestprotocolisanintegralpartofthequalificationplaninaccordancewiththequalificationmasterplan0915andis
validattheIxbergsiteforthequalificationofnewandexistingmanufacturingandcontrolequipmentforpharmaceutical
products.Itdoesnotrelatetothequalificationofcomputersystems.Thisdocumentmustalsobeusedifthequalification
(orpartsthereof)istobecarriedoutbyexternalcompaniesorconsultants.

2. Testitem

Subjectofthetestisthesafetydevicesandalarmsofthefacilitytobequalified.

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3. Performanceoftest

PracticalcheckingofallsafetydevicesandalarmsandcomparisonwiththerequirementsoftheDQ.Everysafetydevice
ischeckedthreetimes.
Theacceptancecriterionis:Thealarm/safetydevicemustbeactivatedassoonasthespecifiedswitching/requiredvalue
isreached.

4. Testlist

Testfeature Switching/ Actualvalue Accepted Date Signature

requiredvalue (Y/N)

Emergencystop

1.

2.

3.

4.

5.

Alarms

1.

2.

3.

4.

5.

5. Testresult

Accepted

Notaccepted,dueto Measuresrequire

6.F.1.2Riskanalysisoperatingfunctions

Figure6.F4OQtestprotocol2

OQqualificationplan
OQtestprotocol2:
Company RiskanalysisOperatingfunctions Pagexv.y

Qualification
projectno. Facility/equipment

Recordcompiled
(Date/signature)

Recordapprovedforimplementation
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(Date/signature)

Testcarriedout
(Date/signature)

Testresultapproved
(Date/signature)

1. Scope

Thistestprotocolisanintegralpartofthequalificationplaninaccordancewiththequalificationmasterplan0915andis
validattheIxbergsiteforthequalificationofnewandexistingmanufacturingandcontrolequipmentforpharmaceutical
products.Itdoesnotrelatetothequalificationofcomputersystems.Thisdocumentmustalsobeusedifthequalification
(orpartsthereof)istobecarriedoutbyexternalcompaniesorconsultants.

2. Testitem

Thesubjectofthistestprotocolistoidentifyalloperatingfunctionsofthefacilitytobequalifiedthatcouldinfluencethe
qualityoftheproduct(critical).Faultlessoperationofthesecriticaloperatingfunctionsischeckedinfurthertestprotocols
(OQ3OQ8).

3. Performanceoftest

1.Thefunctionalityofthefacilityisvisualizedbyadetailedflowchart(tobeenclosedwiththistestintheprotocolasan
appendix).
2.Ifthefacilityistobeoperatedindifferentmodesofoperation,e.g.fordifferentproducts,allmodesofoperationmustbe
takenintoaccountintheflowchartorinseveralflowcharts.
Foreveryoperatingfunctionshownintheflowchart(e.g.stirring,temperaturemeasurement,automat.ejection,etc.)arisk
assessmentmustbecarriedoutinaccordancewithSOP239834.Everyoperatingfunctionassignedwithariskpriority
numberof4,istobeconsideredasqualityinfluencingorcriticaloperatingfunctionandmustbeaddressedinthe
contextoffurthertesting.

4. Testlist

Testfeature Possible Failure Control Probability Importance Probability Riskpriority Quality

failure implications measure of numberRPN relevant
detection operating
function
(yes/no)

Operatingfunction

4.1

4.2

4.3

4.4

4.5

4.6

1. Enclosure

(Flowcharts)

6.F.1.3Checkforthepresenceofscrewcaps

Figure6.F5OQtestprotocol3

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Qualificationplan
TestprotocolOQ3:
Company Verificationofthecheckforthepresenceofscrewcaps Pagexv.y

Qualificationplanforfacilitiesandequipment validfrom
QP08154730 forpharmaceuticalproductsattheIxbergsite 01.10.2003

Qualification
projectno. Facility/equipment Inventoryno.

Recordcompiled
(Date/signature)

Recordapprovedforimplementation
(Date/signature)

Testcarriedout
(Date/signature)

Testresultapproved
(Date/signature)

1. Scope

Thistestprotocolisanintegralpartofthequalificationplaninaccordancewiththequalificationmasterplan0915andis
validattheIxbergsiteforthequalificationofnewandexistingmanufacturingandcontrolequipmentforpharmaceutical
products.Itdoesnotrelatetothequalificationofcomputersystems.Thisdocumentmustalsobeusedifthequalification
(orpartsthereof)istobecarriedoutbyexternalcompaniesorconsultants.

2. Testitem

Verificationofthefaultlessoperationofthecheckforthepresenceofscrewcaps,whichwasclassifiedascriticalin
accordancewiththeriskanalysisofoperatingfunctions(OQ3,DocumentQP08154722).

3. Performanceoftest

Thefacilitytobequalifiediscurrentlyoperatedwithscrewcapsintwodifferentdimensions(Prod#894523and894525).
Thetestsdescribedbelowaretobecarriedoutwithbothscrewcapsaftersizechangeoverofthecorresponding
components.

TestA:
1. Fillthestoragecontainerwithscrewcapstoapprox.2/3.Ensurecontinuousbottlefeed.
2. Startthefacility(speedapprox.3,500).
3. Letthefacilityrunfor15minutes+/1minutewithoutfurthercorrectiveintervention.Whiledoingso,collectthe
undamagedproductandwastebottlesseparately.
4. Checktheundamagedproductformissingscrewcaps.Checkthewasteforthepresenceofscrewcaps.

TestsBandC:
Repeatpoints14atahigherspeed(6,000and7,500).

TestD:
Repeatpoints14whilethescrewlidsupplycontainerisrunningempty.

Challengetest1:
Setthemachinespeedto3,500.Removeeverysecondscrewlidfromthefeedchannel.

Challengetest2:
Setthemachinespeedto6,000.Inserteveryfifthscrewlidintothefeedchannelupsidedown.

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Acceptancecriteria:
1.Innoneofthetestsshouldabottlewithoutascrewlidhaveenteredintotheundamagedproduct.
2.Nomorethan2%ofallthebottlesusedshouldbeincorrectlyrejectedaswaste(i.e.despitecorrectlyappliedscrewlid).

5. Testlist

Testing Numberofundamagedproductitems Numberofwasteitems Accepted Date Signature

(Y/N)
with without without with
lid lid lid lid

Challengetest1:

Challengetest2:

6. Testresult

Accepted

Notaccepted,dueto Measuresrequired

6.F.1.4OQreport

Figure6.F6OQqualificationreport

Company QualificationreportOQ Pagexv.y

Qualificationplanforfacilitiesandequipmentfor validfrom
QP08154730 pharmaceuticalproductsattheIxbergsite 01.10.2003

Qualificationprojectno. Facility/equipment Inventoryno.

Recordcompiled
(Date/signature)

Recordapprovedforimplementation
(Date/signature)

Testcarriedout
(Date/signature)

Testresultapproved
(Date/signature)

1. Scope

ThisqualificationreportsummarizestheresultsoftheOQinaccordancewiththequalificationmasterplan0915.Itisvalid
attheIxbergsiteforthequalificationofnewandexistingmanufacturingandcontrolequipmentforpharmaceuticalproducts.
Itdoesnotrelatetothequalificationofcomputersystems.

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Thisdocumentmustalsobeusedifthequalification(orpartsthereof)istobecarriedoutbyexternalcompaniesor
consultants.

2. OQtests

Testfeature Acceptance Date Signature

criterion:
OK

2.1Checkforelectromagneticcompatibility

2.2Checkingofsafetydevicesandalarmsin
accordancewithtestprotocolOQ1

2.3Identificationofthequalityinfluencing(critical)
operatingfunctionsinaccordancewithtestprotocol
OQ2

2.4.Checkingofthequalityinfluencing(critical)
operatingfunctionsinaccordancewithtestprotocol
OQ37

2.5Checkoftheenvironmentalconditions

2.6Testrunofthefacility(adjustmentofprocess
parameters,placebo)

2.7Testingofmeasuringandcontroltechnology
equipment

2.8Testingoftheautomation(processcontrolsystem)

2.9Testingofdatatransfertointerfaces

2.10

2.11

2.12

2.13

2.14

3. Comments

4. Qualificationresult

Accepted

Notaccepted,dueto Measuresrequired

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6.F.2Example:Fluidbeddryer
Onlythemeasuresthatmustbecarriedout(sometimesusingforms)duringoperationalqualificationarelistedbelowusing
afluidbeddryerforillustrationpurposes.ComputervalidationmeasuresaredealtwithinChapter9ComputerSystem
Validation.

Testequipmentrequiredforqualification
Thetestequipmentrequiredtocarryouttheoperationalqualification(OQ)mustbelisted(seeFigure6.F7).Itmustbe
ensuredthatthecalibrationcanbetracedbacktocertifiedstandards,e.g.nationalnorms,NIST(NationalInstituteof
StandardsandTechnology)orcorrespondinginstitutions.Itmustbecheckedthatthetimeintervalpriortorecalibrationhas
notbeenexceeded.Copiesofthedocumentsfromthelastcalibrationofthetestequipmentusedmustbeincludedwiththe
equipment/qualificationdocuments.

Figure6.F7OQformtestingequipment

Description Calibration Dateoflast Date/

ofequipment Manufacturer Serialnumber interval calibration signature

Stopwatch Solex

Multimeter Fluke

Calibrations
ThequalityrelevantM&Cpoints(measuringandcontrolpoints)havebeennamed.Acopyofthecompiledlistcanbefound
intheinstallationqualificationreport.Themeasuringcircuitsmustbecalibratedbeforetheoperationalqualificationiscarried
out.AcopyofthecalibrationreportissavedintheOQreport(seeChapter4.FCalibration).

Alarms
Allalarmsthatindicatemalfunctionsinthefacilitymustbecheckedbysimulatingtheappropriatemalfunctions.Thetypeof
simulationmustbedescribedontheformanddocumented.Caremustbetakentoensurethatonlyauthorizedpersonnel
carryoutthesesimulations.Allstepsmustbedocumented.

Safetydevices/locks
Allsafetydevicesinthefacilitymustbecheckedtomakesurethattheyarefunctioningcorrectly.Safetydevicesmeans
allequipmentthatprotectstheoperatorfrompersonalinjuryandthefacilityfromimproperhandling.Thetestsmaybe
documentedwiththeaidoftheform(seeFigure6.F8).

Figure6.F8OQformsafety

functioning
correctly Date/
No. Facility Description yes/no signature

1 Emergency Thefacilityhaltsoperationassoonasthebuttonispressed.Allmotorsandpumpsareswitchedoffand
stopbutton thevalvesforutilitiessupplyarenolongersuppliedwithelectricity.

Presstheemergencystopbuttonwhenthefacilityisinoperation:

Allmotorsstopmoving.

Thevalvesfortheutilitysupplyareclosed.

Flowratetest
Thefacilityisstartedwithaflowrateof1000m3 /hwithoutheatingoutputandwithoutproduct(thiscorrespondstothe
minimumcapacity).Theairvelocityismeasuredandrecordedatthreedifferentmeasuringpoints.Thismeasurementisthen
repeatedwithaflowrateof3500m3 /hand6000m3 /h.Thevaluesdeterminedatthevariousmeasuringpointsarecompared
withoneanotherandassessed.Thetestisdocumentedusingaform.

Volumeflowregulation

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Acheckmustbecarriedouttoverifythattheflowrateisbeingcontrolledcorrectlyusingthreedifferentflowrates.This
involvesstartingthefacilitywithaflowrateof1000m3 /hwithoutheatingoutputandwithoutproduct.Thissettingis
maintainedfor15minutes.Theflowrateisthenincreasedto3500m3 /hforafurther15minutesandthenfinallyto6000
m3 /hfor15minutes.Duringthistimethecontrolmustmaintainastablevaluethatfallswithinthespecifiedrange.The
tolerancevaluesarespecifiedonaformwheretheresultsarealsodocumented.

Sprayrate
Thefacilityistobepreparedasifaproductcyclewasabouttobecarriedout.Itisstartedwithaflowrateof2000m3 /h
withoutheatingandwithoutproduct.Thespraymediumtobeusediswater.Measurementsmustbecarriedoutfor10
minuteswiththeminimum,with50%andwiththemaximumsprayratesrespectively.Thesprayquantityisdeterminedby
weighing.Thetrialmustbecarriedoutthreetimesforeachsprayratewhichmustnotdeviatebymorethan5%.Thetests
aredocumentedonaform.

Heatdistribution
Tochecktheheatdistribution,thefacilitymustbepreparedasifaproductcyclewasabouttobecarriedoutanditmustbe
startedwithaflowrateof3000m3 /hwithoutaproductload.Thetemperatureissetat50C.Followingafiveminutewarm
upphase,thetemperatureismeasuredatfivedifferentpointsabovethesievescreenfor10minutes.Noneofthemeasured
valuesmaydeviatebymorethan5Cfromtheaveragevaluedeterminedabovethescreen.Thetrialisrepeatedat80C
and110C.Thetestresultsaredocumentedonaform.

Temperaturecontrol
Thetemperaturecontrolischeckedwithoutaproductwithaflowrateof5000m3 /h,at50C,80Cand110Crespectively.
Afterthefiveminutewarmupphasethetemperaturemustsettledowntoaconstantlevelwhichismaintainedfor10
minutes.Thesameprocedureisthencarriedoutfortemperaturesof80Cand110Crespectivelyandthecontrolchecked.
Thedeviationsmustnotbemorethan5Cfromthepresetvalue.Theresultsmustbedocumented.Aprintoutoftheplot
mustbeincludedwiththeOQreport.

Screenmasks
Checksmustbecarriedouttoverifywhetherthescreenmasksperformthefunctionstheyhavebeenassigned.Itmustbe
ensuredthattheoperationalparameterscanbemodifiedwithintheirassignedlimits.Itmustbepossibletosavenew
formulationswiththeprogramedoperationalparametersandretrievedataagain.Thetemperature,humidityandpressure
valuesdisplayedarecheckedduringcalibration.Ahardcopyofeachscreenmaskmustbemadeandamendedtotheform.

Equipmentfunctions
Thisinvolvestestingofspecificfunctionsofthefacilitysuchastheon/offorraise/lower.Thedecisionastowhichtests
shouldbecarriedoutisbasedonresultsfromtheriskanalysis(seeChapterD.7).Thetestsaredocumentedonaform.

Productcycle
Tochecktheentiresequenceoffunctionsincontext,atrialrunmustbecarriedoutwiththeproduct.Themanufacturing
instructionsfortheproductmustbeusedasthebasisforthetrialrun.Thefinalproductistestedinaccordancewiththe
approvedtestspecifications.Theperformanceofthetestandtheresultsmustbedocumented(seeFigure6.F9).The
productcycledatamaybeusedaswellfortheperformancequalificationandprocessvalidation.

Figure6.F9OQformproductcycle

Resultscorrect:
Productcycle yes/no

Theproductcyclewasimplementedinaccordancewiththemanufacturinginstructions.

Itwaspossibletoimplementtheproductcyclewithoutinterruption.

Themanufacturingstepswereprocessedcorrectly.

Thestepenablingconditionswereachievedandidentified.

Noprocessrelatedmalfunctionsoccurred.

Thepresetprocessparameterswerecompliedwith.

Theproductwastestedinaccordancewithexistingguidelinesandcorrespondswiththespecifications.

Comments:
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Comments:

Date/signature:

Batchrecord
Therecordingofabatchstartswhentheprocessbeginsandendswhenthecontainerislowered.Itmustbeensuredthatthe
processdataenteredandthemeasuredvaluesgatheredinthebatchrecordarereproducedcorrectly.Tocheckthis,the
batchrecordforthetestrundescribedabovemustbeadditionallyrecordedmanuallyonaform.Oncethetrialhasended,
thebatchrecordwhichisgeneratedautomaticallyiscomparedwiththemanuallyrecordeddata.Theremustbeno
deviations.

Databackup
Checksmustbecarriedouttodeterminehowthesystemrespondsintheeventofapower/utilitiesfailure.Itmustbe
ensuredthattheoperatingdatathathasaccumulateduptothispointisnotlostintheeventofasuddenpower/utilities
failure.Thefacilitymustalsobecapableofcontinuingwiththelastprocessstatusfollowingrestorationofthepower/utilities
andsubsequentconfirmation.Theremustbenodeviationsintheparameterssetortheprocessdata.Thetestis
documentedusingaform.

Accessprotection
Itmustbedemonstratedthatunauthorizedindividualscannotaccessthesystemandmanipulatedata.Acheckmustbe
carriedouttodeterminewhetheroperationalparameterscanonlybemodifiedbyauthorizedpersonnel.Thetestis
documentedusingtheform.Thisshouldincludethetestprocedureandthespecificresultsobtained.

Deficiencyreport
Deviationsidentifiedduringtheoperationalqualificationmustbedocumentedinthedeficiencyreport.Theresponsible
departmentdefinescorrectiveactions,namesthedepartmentsorpersonsresponsible,specifiesdeadlines,andinitiates
implementationofthemeasures.Allcorrectivemeasuresperformedmustbedocumented.

Itmustbeensuredthatchangesmade,asaresultofcorrectiveactions,areassessedanddocumentedinaccordancewith
theestablishedchangecontrolprocedures,andarequalificationcarriedoutasrequired.Allaffectedproceduresshouldbere
issuedwithanyrevisionsrequiredtoaddressthechangesmadetoanyprocedure.

6.FSummary
Duringoperationalqualification(OQ)thefunctionalityoftheinstalledequipmentintheintendedworkingareaistestedand
documented.Theriskanalysisformsthebasisforthetestingscopeattheindividualqualificationsteps.Deviationsthat
occurcanleadtoaninterruptionofthequalificationactivities.Theymustbeeliminatedanddocumented.Successful
executionoftheIQandOQisrequiredtoreachthequalifiedstatusforafacility.

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