Documenti di Didattica
Documenti di Professioni
Documenti di Cultura
*
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
Doudi