Lecture3:DocumentationandValidation

*
Recall
:Premise
Personnel

Premise
:
1)
Heating,ventilationandairconditioning
:(HVAC)

Level1=General:Areawithnormalhousekeepingandmaintenance.
Level2=Protected:Areawithproductfromcontamination
Level3=Controlled:Areawithtemperaturemonitored

2)
HVACsystemparameter
s:

RelativehumidityOperationofdedusting
Roomcleanuprates
Roomparticlecounts
Warning/alarmsystems

Personnel
:Safety/Hygiene/Qualified

*
Documentationtypes
:Specifications/Records/OperationalProcedures/Master
Formulae

Specifications
:definedasthelistofteststhatdefinethestandardqualityofagivenmaterial.:

1)ManufacturerInformation
2)physicochemicalproperties
3)testingdirections
4)Qualitativeandquantitativerequirements
5)StorageConditionsandshelflife

MasterFormulae
:Adocumentspecifyingtherawmaterialswiththeirquantitiesandthe
packagingmaterialsaswellastheprocessinginstructions,includingtheinprocesscontrols.

StandardOperatingProcedure
:Astepbystepdocumentationforoperatingacertainprocess:

1)OperationalProceduresforspecificequipment5)Testingprocedures
2)ValidationProcedures
3)PersonnelcautionaryProcedures

4)Samplingprocedure

Records
:Informationthatshouldberecordedatthetimeanactionistakenandcompletedby
thepersonwhodidit:

1)BatchproductionRecord
2)BatchPackagingRecord
3)LaboratorycontrolRecord

*
Validation:

ValidationVs.Qualification:

Reportsandprotocols
:

1)Theobjectivesofthestudy
2)Thesiteofthestudy
3)Theresponsiblepersonnel
4)Equipmenttobeused

ApproachestoValidation
:

1)ProspectiveandConcurrentvalidation:Basedonevidenceobtainedthroughtesting(before
andduringproduction)

2)Retrospectivevalidation:Basedontheanalysisofhistoricaldata(notpreferred)

QualificationStages
:

1)DesignQualification:showsthatthedesignspecificationsweremet
2)InstallationQualification:showsthattheinstallationwascompleteandsatisfactory
3)OperationalQualification:showsthatallcomponentsoperateinaccordancewithoperational
specification
4)PerformanceQualification:showsallcomponentscanconsistentlyperforminaccordance
withthespecificationsunderroutineus

CalibrationandVerification
:

Calibrationandverificationofequipment,instrumentsandotherdevices,asapplicable,usedin
productionandqualitycontrol,shouldbeperformedatregularinterval.

ChangeControl
:

1)Processshouldbedoneunderthecoordinationofachangecontrolmanagement

2)ChangesshouldbecontrolledinaccordancewithaSOP
3)Describeifthereisqualificationorvalidationtobedone
4)Changesshouldbeformallyrequested,documentedandapprovedbeforeimplementation.

*
CaseStudiesandanswers:

Case1:(Changemanagement/riskassessment)DuringaSecondarypackagingprocessthe
linestoppedandanalarmwentonindicatinga
certainfailureormalfunctionintheline.Afterextensiveinvestigationsandengineering
teaminterferences,itwasdiscoveredthatasparepartneedstobechangedASAPto
continuethepackagingprocess.Theengineeringsupervisorwentstraightaheadtothe
procurementteamraiseaPOtogetthissparepartimmediately.Oncethissparepartwas
receiveditwasinstalledandthelineworkednormallyfineandthebatchwascompletely
packedandfinalized.
TheQualityassuranceofficerwasreviewingthissamebatchtohaveitreadytobereleased
tothemarket,andhethoroughlyexaminedallcommentsregardingthelinefailureinthe
middleoftheprocessandalongwithanyothercommentsorrelatedincidents/
investigationstothisbatch.
TheQAofficerrefusedtoreleasethisbatch.Whydoyouthinkthishappened?

Answer:Therequiredsparepartwaschangedwithoutany
documentationrecordingthisevent,whichisnotacceptedaccordingtotheGMPrules&
regulations.Hemustrecordariskassessmentdocument.

Case2:(TrainingManagement)
AQAofficerwashavingthedailytouraroundtheproductionarea,tomakesurethatall
processesarecompliantwithallproceduresandinstructions.Alonghistourhefoundanew
processingoperatorinoneofthemanufacturingroomsworkingonabatch.TheQAwentin
togettoknowhim,andthroughoutthediscussionitwasclearenoughthatthisnew
operatorhadmorethan10yearsofexperience,whichislogicallyenoughtostartworking
fromtheveryfirstday.Insteadofjustpassingby,theQAofficerdecidedtoraiseaQuality
investigation/Incident.Whydoyouthinkthishashappened?

Answer:Nomatterhowexperiencedany1canbe.Traininghastobecompletedaheadof
touchinganymachineryorstartinganyproductanalysis.

Case3:(Documentationandvalidation)
Awarehouseoperatorhadaverygoodideathatcouldsavealotoftimeduringthe
receivingprocesshewentandaskedhislinemanagerandQAofficertoupdatethe
requireddocumenttoreflectthesechanges.Thewarehouseoperatorappliedthechanges
immediatelyandsimultaneouslythedocumentwasbeingupdated.
Doyoufindanythingwrongwithwhatthewarehouseoperatordid?

Answer:Anynewprocessneedstobevalidated&documentedaheadofapplication.
Bahebek
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