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  • Good Laboratory PracticeGood Laboratory PracticeGoodLaboratoryPracticeGoodLaboratoryPracticeHowCriticaltoQualityHowCriticaltoQuality

    R RaghunandananR RaghunandananRRaghunandananRRaghunandanan

    MumbaiMumbai

    55thth June2015June2015

    05June2015 RRNANDAN@GMAIL.COM 1

  • GoodLaboratoryPracticey

    Scopeofthissession

    GLP from a Regulatory perspectiveGLPfromaRegulatoryperspective

    GLPfromaQualitySystemperspective

    05June2015 RRNANDAN@GMAIL.COM 2

  • IntroductionIntroductionIntroductionIntroduction

    05June2015 RRNANDAN@GMAIL.COM 3

  • WhatisGoodLaboratoryPracticeGLPisNOTjustsomegoodpracticesinaLaboratoryLaboratory

    GLPisaQualitySystemconcernedwiththeorganizationalprocessandtheconditionso ga at o a p ocess a d t e co d t o sunderwhichlaboratorystudiesare Planned,PerformedandMonitored, Recorded,ReportedandArchived

    Thus GLP covers the whole gamut ofThusGLPcoversthewholegamutofLaboratoryProcesses

    05June2015 RRNANDAN@GMAIL.COM 4

  • Why Good Laboratory PracticeWhyGoodLaboratoryPractice

    ThepurposeofGLPisto Ensurequalitytestdata Ensure sound laboratory management Ensuresoundlaboratorymanagement Ensurerobustconductanceoflaboratoryt titesting

    Ensureaccuratereportingoftestfindings Ensuresafearchivaloflaboratorydata

    05June2015 RRNANDAN@GMAIL.COM 5

  • LaboratoryDataIntegrityDataintegrityisverycritical Analyticalresultsshouldshould

    Accuratelydescribethepropertiesofthesamples assessedsamplesassessed

    Permitcorrectconclusionstobedrawnaboutth lit f th lthequalityofthesamples

    Formthebasisforanysubsequentadministrativeandlegalactions

    Formthebasisforanycustomerresponses

    05June2015 RRNANDAN@GMAIL.COM 6

    y p

  • LaboratoryDatal b lGlobalAcceptance

    L b t d t i t it h i t t Laboratorydataintegrityhasanimportantinternationaldimension

    Gl b l t f C f AGlobalacceptanceofCofADuplicativetestingcanbeavoidedC t d t ti d i d tCostssavedtonationandindustryFasterdisposalofregistrationsubmissions

    05June2015 RRNANDAN@GMAIL.COM 7

  • GLPGLPCompliancePerspectiveCompliancePerspective

    05June2015 RRNANDAN@GMAIL.COM 8

  • GoodLaboratoryPracticeCompliancerequirements

    The Drugs and Cosmetics Act 1940TheDrugsandCosmeticsAct,1940 ScheduleL1onGLPeffectiveNov2010S h d l S i Q li ScheduleM Section14onQualityAssuranceandSection16onQualityControlmentionsb GLPaboutGLP

    ScheduleUPartIII ParticularstoberecordedinAnalyticalRecordspertainstoGLP

    05June2015 RRNANDAN@GMAIL.COM 9

  • GoodLaboratoryPracticelCompliancerequirements

    21CFRPart211,USFDAcGMP SubpartI,LaboratoryControl stipulatesp , y pdetailedlaboratorycontrolstobefollowed

    05-June-2015 RRNANDAN@GMAIL.COM 10

  • GoodLaboratoryPracticeCompliance req irementsCompliancerequirements

    EU GMP EudraLex Volume 4 Part 1 updatedEUGMPEudraLexVolume4,Part1,updatedversioneffectiveOctb2014

    Chapter 6 Quality ControlChapter6 QualityControlMentionsGoodQCLaboratoryPractice,

    i l d il d lstipulatesdetailedcontrolmeasures

    RecentGuidelinefromMHRAonDataIntegrityessentiallydealswithGLP

    05-June-2015 RRNANDAN@GMAIL.COM 11

  • GoodLaboratoryPracticeCompliance req irementsCompliancerequirements

    WHO GMP GuidelinesWHOGMPGuidelines TRS957Annex1 WHOGoodPracticesforPharmaceutical QC LaboratoriesPharmaceuticalQCLaboratories

    TRS961Annex2 WHOGoodPracticesforPh i l Mi bi l L b iPharmaceuticalMicrobiologyLaboratories

    OtherstatutesandGuidelineslikeICHQ7

    05-June-2015 RRNANDAN@GMAIL.COM 12

  • GoodLaboratoryPracticeCompliancerequirements

    Thus compliance is mandated Thuscomplianceismandated Complianceisessential

    ForpatientsafetyprimarilyMeetingregulatoryexpectationsMeeting regulatory expectations ForhighlevelofcustomerconfidenceIn dealing ith an f t re litigations Indealingwithanyfuturelitigations

    05-June-2015 RRNANDAN@GMAIL.COM 13

  • GLPGLPQ li S P iQ li S P iQualitySystemPerspectiveQualitySystemPerspective

    05-June-2015 RRNANDAN@GMAIL.COM 14

  • OrganizationOrganization

    05-June-2015 RRNANDAN@GMAIL.COM 15

  • Organizationg Managementresponsibility

    D fi i L b l dDefiningLaboratorymanagersroleandresponsibilitiesI d d f l b f i (QC&QA) Independenceoflaboratoryfunction(QC&QA)

    GLPcompliancemustbereferredtointheQ li M lQualityManual

    MakingresourcesavailableControlsonexternaltestinglabsifanyUseofmetricsrelatedtolaboratoryoperations

    05-June-2015 RRNANDAN@GMAIL.COM 16

  • Laboratory Facilities (1)LaboratoryFacilities(1)

    05June2015 RRNANDAN@GMAIL.COM 17

  • Laboratory Facilities (1)LaboratoryFacilities(1)

    Afactorthatisoverlookedinmanyorganizationsy g Effectiveandaccuratelaboratoryactivitiespossible only if adequate space is providedpossibleonlyifadequatespaceisprovided

    Adequatespaceincludes samplereceivingandstorage areas testing areas chemical storagestorageareas,testingareas,chemicalstorageareas,glasswarewashingareas,officeareas,retention sample storage areas documentretentionsamplestorageareas,documentstorageareas,trainingroometc.

    05June2015 RRNANDAN@GMAIL.COM 18

  • Laboratory Facilities (2)LaboratoryFacilities(2) Logicalworkflowtoavoidcrisscrossmovements Crisscrossmovementskillsproductivemanhoursinthelaboratoryy

    Considerspacerequirements10yearsaheadand make provisionsandmakeprovisions

    ApplyprinciplesofLeanLab

    05June2015 RRNANDAN@GMAIL.COM 19

  • Personnel and trainin (1)Personnelandtraining(1)

    05June2015 RRNANDAN@GMAIL.COM 20

  • Personnel and training (1)Personnelandtraining(1)

    PeoplemakeorbreaktheGLPsystems Gettingqualifiedandexperiencedanalystswith the right attitude is a challenge todaywiththerightattitudeisachallengetoday

    Responsibilitiesshouldbedefined,communicated and documented to avoidcommunicatedanddocumentedtoavoidoverlapping

    05June2015 RRNANDAN@GMAIL.COM 21

  • Personnel and training (2)Personnelandtraining(2)

    Meretrainingisnotenough Organizationsshouldhavedevelopmentplansfor the laboratory staff that only can helpforthelaboratorystaff thatonlycanhelpretainthem

    Talent identification and development plans Talentidentificationanddevelopmentplans Successionplansshouldbeinplace

    05June2015 RRNANDAN@GMAIL.COM 22

  • Personnel How crucial they are ?Personnel Howcrucialtheyare?

    Goodfacility+Goodsystems+Rightpeople=Goodproduct

    Averagefacility+Goodsystems+Rightg y y gpeople=Goodproduct

    Average facility + Average systems + RightAveragefacility+Averagesystems+Rightpeople=Goodproduct(stillpossible)

    Good facility + Good systems + Not the rightGoodfacility+Goodsystems+Nottherightpeople=Poorproduct

    05June2015 RRNANDAN@GMAIL.COM 23

  • Laboratory Equipment (1)LaboratoryEquipment(1)

    05June2015 RRNANDAN@GMAIL.COM 24

  • Laboratory Equipment (1)LaboratoryEquipment(1)

    Scienceandtechnologyprogressedseveralfoldsduringthelastdecades

    Automation is the answer for many of theAutomationistheanswerformanyofthelaboratoryillness

    Ideally all needed equipment should be Ideallyallneededequipmentshouldbeavailable

    O t i t t l if j tifi d Outsourcinganytestsonlyifjustified

    05June2015 RRNANDAN@GMAIL.COM 25

  • Laboratory Equipment (2)LaboratoryEquipment(2)

    Equipment qualification calibration andEquipmentqualification,calibrationandmaintenance

    Controls on computerized systems in line with Controlsoncomputerizedsystemsinlinewith21CFRPart11andEUGMPAnnex11

    A id d i i b h i l i Avoiddataintegritybreachesinvolvingcomputerizedsystemsinthelaboratorybyh i b lhavingrobustcontrols

    05-June-2015 RRNANDAN@GMAIL.COM 26

  • Chemicals and reagentsChemicalsandreagents

    05June2015 RRNANDAN@GMAIL.COM 27

  • Chemicals and reagentsChemicalsandreagents

    Chemicals,reagentsandreferencesubstancespayavitalroleinthecorrectnessoflaboratoryresults

    Microbiologicalculturesandmedia Traceability in all recordsTraceabilityinallrecords Uncontrolledcostcuttinginthisareacouldlead to increased number of laboratoryleadtoincreasednumberoflaboratorydeviationsandOOSresults

    05June2015 RRNANDAN@GMAIL.COM 28

  • Sampling and TestingSamplingandTesting

    05June2015 RRNANDAN@GMAIL.COM 29

  • Sampling and TestingSamplingandTesting

    Samplingisacriticalactivity Samplingshouldbedonebytrainedpersonnel Sample identification, samples controls andSampleidentification,samplescontrolsandsampledispositionshouldbeasperwrittenproceduresprocedures

    Samplingofstabilitysamplesasperwrittenprocedures for stability testingproceduresforstabilitytesting

    05June2015 RRNANDAN@GMAIL.COM 30

  • Sampling and TestingSamplingandTesting

    Pharmacopoeialtestproceduresshouldbeverified

    Othertestproceduresshouldbevalidatedp Concurrentrecordingoftestresults Trending of test results Trendingoftestresults Stabilitytestingasperwrittenprocedures

    05June2015 RRNANDAN@GMAIL.COM 31

  • Laborator Doc mentation (1)LaboratoryDocumentation(1)

    05June2015 RRNANDAN@GMAIL.COM 32

  • Laboratory Documentation (1)LaboratoryDocumentation(1)

    Documentation is key to the laboratoryDocumentationiskeytothelaboratoryprocess

    Laboratory documentation Manual system,Laboratorydocumentation Manualsystem,electronicsystemorahybridsystem

    Robust controls for original raw data andRobustcontrolsfororiginalrawdataandtraceability

    Secured storage of documentsSecuredstorageofdocuments

    05June2015 RRNANDAN@GMAIL.COM 33

  • Laboratory Documentation (2)LaboratoryDocumentation(2)

    Equipment qualification documentsEquipmentqualificationdocuments Methodvalidationd

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