HPLCIQOQWord文档下载推荐.docx

HPLCIQOQWord文档下载推荐.docx

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entitledAnalyticalInstrumentQualification

（2）.

Followingaliteratureandregulatoryoverview,thisprimerwillprovideinformationontheentirequalificationandvalidationprocessfromplanning,writingspecificationsaswellasvendorqualificationtoinstallation,initialandon-goingoperation.

Itcovers:

∙Literatureoverviewwithmilestonesoninstrumentqualificationandsystemvalidationinlaboratories.

∙Overviewonregulationsandqualitystandardswithimpactonanalyticalinstrumentqualification.

∙Qualificationofequipmenthardware,forexample,aspectrometerorliquidchromatograph.

∙Validationofanalyticalcomputerizedsystems.

∙ImplementingUSPchapter<

.

SpecialfocusisplacedongettingagoodunderstandingofandimplementingUSPchapter<

.Afteranintroductiontothechapter’sapproachforinstrumentqualification,thisprimerwillleadyouthroughindividualqualificationphasesandgiverecommendationsforimplementation.Theprimerwillnotonlyhelpreadersunderstandtheinstrumentqualificationprocess,butalsoofferstemplatesandexamplestoeasilyimplementqualification.Becauseofthenatureandsizeofthisprimer,allthedetailsofoperationalqualificationandsystemvalidationcannotbegiven.Formoredetails,pleaserefertoreferencearticlesandtextbooks（3-5）.Exactproceduresandtestparametersverymuchdependonthetypeofinstrumentandapplications.Detailsonrecommendationsandservicescanbeobtainedfrominstrumentvendors.Althoughtheprimerhasrecommendationsforvalidationofstandardcommercialcomputerizedanalyticalsystemswithouttheneedformajorcustomization,itdoesnotgivedetailsonvalidationofcomplexsystems,suchasLaboratoryInformationManagementSystems（LIMS）,oronvalidationactivitiesduringsoftwaredevelopmentbutreferstofurtherliterature（7-11）.

LiteratureOverview

Duetotheirimportance,equipmentqualificationissueshavebeenaddressedbyseveralorganizations.Before1990theregulatoryfocusofinstrumentandcomputervalidationwasprimarilyonmanufacturingequipment,whichchangedafter1990.Inresponsetoindustrytaskforces,regulatoryagenciespublishedguidancedocumentsthathelpedtheindustrytobetterunderstandregulatoryrequirements.Inaddition,privateauthorspublishedreferencebookswithpracticalrecommendationsforimplementation:

∙ThePharmaceuticalAnalysisScienceGroup（UK）developedapositionpaperonthequalificationofanalyticalequipment（6）.Thispaperwasabenchmarkbecauseitintroducedthe4Qmodelwithdesignqualification（DQ）,installationqualification（IQ）,operationalqualification（OQ）andperformancequalification（PQ）foranalyticalequipmentqualification.

∙TheLaboratoryoftheGovernmentChemist（LGC）andEurachem-UK,developedaguidancedocumentwithdefinitionsandstep-by-stepinstructionsforequipmentqualification（3）.

∙TheUnitedStatesFoodandDrugAdministrationdevelopedprinciplesofsoftwarevalidation（7）.

∙TheGoodAutomatedManufacturingPracticesForum（GAMP）developedguidelinesforcomputervalidationin2001（8）andin2008（9）.Theseguideshavebeenspecificallydevelopedforcomputersystemsingeneral,andbecauseoftheirimportancehavealsobeenusedforvalidationoflaboratorysystems.

∙GAMPalsopublishedaGoodPracticeGuideforValidationofLaboratorySystems（10）.Itrecommendsvalidationactivitiesandproceduresforsevendifferentinstrumentcategories.

∙Huberauthoredtwovalidationreferencebooksfortheanalyticallaboratory（5,11）.Thefirstonecoversallvalidationaspectsofananalyticallaboratoryincludingequipment,analyticalmethods,referencecompoundsandpeoplequalification.Thesecondonecoversthevalidationofcomputerizedandnetworkedsystemsinanalyticallaboratories.

∙TheParenteralDrugAssociation（PDA）developedatechnicalpaperonthevalidationoflaboratorydataacquisitionsystem（12）.

∙Coombesauthoredabookonlaboratorysystemsvalidationtestingandpractice（4）.Thetermlaboratorysystemsvalidation（LSV）wasusedtomakeadistinctionfromcomputersystemvalidation（LSV）andequipmentqualification（EQ）.

∙ChanandcolleaguespublishedthebookAnalyticalMethodValidationandInstrumentPerformanceVerification（13）.Thisbookhasseveralchapterswithpracticalrecommendationsforinstrumentqualification.

∙PIC/SdevelopedagoodpracticeGuideforUsingComputersinaGxPEnvironment（14）.Thisdocumenthasbeenwrittenbyinspectorsforinspectorsasaguidetoinspectcomputerizedsystems.

Alltheseguidelinesandpublicationsfollowacoupleofprinciples:

∙Qualificationofequipmentandvalidationofcomputersystemsarenotonetimeevents.Theystartwiththedefinitionoftheproductorprojectandsettinguserrequirementspecificationsandcoverthevendorselectionprocess,installation,initialoperation,ongoinguseandchangecontrol.

∙Allpublicationsrefertosomekindoflifecyclemodelwithaformalchangecontrolprocedurebeinganimportantpartofthewholeprocess.

Differentmodelshavebeensuggestedfordifferentkindsofinstruments.Forexample,the4QmodelasdescribedbyFreeman（6）andBedson（3）hasbeenrecommendedforusersofcommercialinstrumentswithoutsignificantcustomizationbytheuser.TheV-modelasrecommendedbyGAMP4（8）issuitableforsoftwaredevelopmentaswellasforusersofcommercialinstrumentswithcustomizationbytheuser.

AmajorbreakthroughcamewhenUSPreleaseditsgeneralchapteronanalyticalinstrumentqualification

（2）.Themajorbenefitofthechapterwasthatitformalizedthe4Qmodelandclarifiedsomeissuesthathavebeenfrequentlydiscussedbefore,forexample,thataninstrument’sfirmwaredoesnotneedseparatequalification,butshouldbequalifiedaspartoftheinstrumenthardware.

Terminology:

Validationvs.Qualification

Anagreementonterminologyisofutmostimportanceforacommonunderstandingofvalidationandqualification.Theauthorhasfrequentlynotedatvalidationsymposiathatdifferentspeakersuseddifferenttermsforthesamethingandthesametermsfordifferentthings.Mostfrequentquestionaroseaboutthewordsvalidationandqualification.USPhasrecognizedthisandaddresseditinaparagraphonthefirstpageofchapter<

.Thewordqualificationrelatestoinstrumentsthatcanbeindividualmodulesandalsosystems,forexample,acompleteHPLCsystemcomprisedofasamplingsystem,apump,acolumncompartmentandadetector.Checkingthebaselinenoiseofadetectorandcomparingtheresultswithpreviouslydefinedspecificationswouldbeanexampleforqualification.Qualificationisdoneindependentlyfromaspecificapplicationorsample.Typicallythetypeofspecificationscanbefoundinthevendor’sproductspecificationsheet.

Thewordvalidationrelatestoapplications,processesandmethods.Forexample,formethodvalidationwespecifythelimitofquantitationorlimitofdetectionofoursamplecompounds.Suchspecificationscanonlybeverifiedwithacompletesystemandaccessoriessuchastherightchromatographiccolumn,calibrationstandardsandSOPsforrunningthetest.

Unfortunately,validationandqualificationarefrequentlyusedinterchangeably.Forexample,forsoftwareandcomputersystemsthetermvalidationisalwaysused,eventhoughaccordingtothepreviousdefinitionqualificationshouldbeused.Therefore,inthecontextofsoftwareandcomputersystems,thisprimerwillalsousethetermvalidation.

TheFDAandotheragenciesdonotreallycarewhatuserscallit,validationorqualification.Theinspector’squestionwillalwaysbe:

howdidyoumakesurethatthedataareaccurate.Aslongasthereisagoodanswer,forexamplethroughvalidationofsystemsandmethods,itisofsecondaryimportancehowuserscallit.However,agreementonterminologyisofutmostimportancewithinacompany,sothateverybodyhasthesameunderstandingofqualificationandvalidation.Therefore,terminologyandtheexactmeaningshouldbedocumentedinaglossary.

ComponentsofAnalyticalDataQuality

ThereweremanydiscussionsabouttheneedforinstrumentqualificationinanalyticallaboratoriesbeforethereleaseofUSP<

takingintoaccountthatthereareseveralothercompone