Pharmaceutical Quality System

  • Published on
    06-Oct-2015

  • View
    7

  • Download
    0

Embed Size (px)

DESCRIPTION

QS

Transcript

<ul><li><p>LearningFromOtherIndustries</p><p>G.K.Raju,PhD</p><p>LightPharmaInc.</p><p>October2011</p><p>1</p></li><li><p>OUTLINE</p><p> Background ICHQ10 LookingatOtherIndustries</p><p>General Specific</p><p> Summary2</p></li><li><p>THEECONOMIST:August31st2002 Pharmaceuticals:Troubleinthemaking</p><p>Foralltheglamourofinvention,thelatest blockbustermedicine,likethehottestnew fashion,canunravelifmanufacturingfalters.</p><p> Witnesstheslewofdrugmakersthathave fallenfouloftheFDA,theirregulatorin</p><p> America..</p><p>3</p></li><li><p>TheWallStreetJournal:September3rd </p><p>2003 NewPrescriptionForDrugMakers:UpdatethePlants</p><p>ThePharmaceuticalIndustryHasALittle Secret:Evenasitinventsfuturisticnew drugs,itsmanufacturingtechniqueslagfar</p><p> behindthoseofpotatochipandlaundry soapmakers.</p><p>Youneedtoimprove </p><p> Dr.McClellanlectured theindustry..</p><p>4</p></li><li><p>TheWallStreetJournal:September3rd </p><p>2003 NewPrescriptionForDrugMakers:UpdatethePlants</p><p>JanetWoodcockwasamongthearchitectsofanFDA Crackdownunderwhichtheagencyfineddrug</p><p> makersasmuchas$500millionformanufacturing failuresinrecentyears.Yetwestillwerentseeing acceptablelevelsofquality, shesaysbecause</p><p> manufacturingtechniqueswereoutmoded.Just refiningproceduresanddocumentationwasnt</p><p> goingtochangethat.</p><p>5</p></li><li><p>OUTLINE</p><p> Background ICHQ10 LookingatOtherIndustries</p><p>General Specific</p><p> Summary6</p></li><li><p>7</p><p>ICHQ10describesonecomprehensivemodelforan effectivepharmaceuticalqualitysystemthatisbased</p><p> onInternationalOrganizationforStandardization (ISO)qualityconcepts,includesapplicablegood</p><p> manufacturingpractice(GMP)regulations,and complementsICHQ8PharmaceuticalDevelopment</p><p> andICHQ9QualityRiskManagement.3</p><p>ICHQ10</p></li><li><p>8</p><p>ImplementationofICHQ10throughouttheproduct lifecycleshouldfacilitateinnovationandcontinual improvementandstrengthenthelinkbetween</p><p> pharmaceuticaldevelopmentandmanufacturing activities.</p><p>ICHQ10</p></li><li><p>OUTLINE</p><p> Background ICHQ10 LookingatOtherIndustries</p><p>General Specific</p><p> Summary9</p></li><li><p>10</p><p>QUALITY</p><p>ClinicalPerformance</p><p>Critical Quality Attributes Process Materials Controls</p><p> API Attributes Impurities </p><p>1.</p><p> Cmax AUC</p><p> Description Identity Assay CU Impurity Dissolution</p><p>1.</p><p>3b.</p><p>Quality System</p><p>2.</p><p>3a.</p><p>3c.</p></li><li><p>11</p><p> Quality FitnessForUse[J.M.Juran] ConformancetoRequirements[Crosby] PlanDoCheckAct(PDCA/PDSA)[Deming/Shewhart]</p><p> Quality QualityofProduct QualityofProcess QualitySystem</p><p>QUALITY</p></li><li><p>Learningfromotherindustries: QualityPhilosophies</p><p> W.EdwardsDeming SystemofProfoundKnowledge</p><p> System,Variation,Knowledge,Psychology 14Principles</p><p> PhilipCrosby QualityisFree</p><p> (1979)</p><p> QualityManagementMaturity</p><p>12</p></li><li><p>Learningfromotherindustries: W.EdwardsDeming</p><p> Abadsystemwillbeatagoodpersoneverytime Lackofknowledge...thatistheproblem. Learningisnotcompulsory...neitherissurvival. Qualityiseveryone'sresponsibility. Weareheretomakeanotherworld.</p><p>13</p></li><li><p>Learningfromotherindustries: FocusandCostofQuality</p><p>14</p><p>CostOfQuality</p><p>Where Right is Measured</p><p>DEVELOPMENT</p><p>WARNING LETTER</p><p>FDA 483RECALLS</p><p>COMPLAINTS</p><p>FINAL QC TESTINGQA APPROVAL </p><p>IN-PROCESS TESTING</p><p>REJECTS </p><p>CONSENT DECREE</p><p>Prevention</p><p>Appraisal</p><p>Internal Failure</p><p>External FailureCommon Focus</p></li><li><p>Learningfromotherindustries: ProcessMaturity</p><p>15WEIGHING</p><p>GRANULATION</p><p>FB DRY</p><p>MILLING</p><p>BLEND</p><p>FILMCOATINGCOMPRESS</p><p>BOTTLEPACKAGINGSYSTEM A:</p><p>WEIGHING</p><p>GRANULATION</p><p>FB DRY</p><p>MILLING</p><p>BLEND</p><p>FILMCOATINGCOMPRESS</p><p>BOTTLEPACKAGING</p><p>SYSTEM B:</p><p>WEIGHING</p><p>GRANULATION</p><p>FB DRY</p><p>MILLING</p><p>BLEND</p><p>FILMCOATINGCOMPRESS</p><p>BOTTLEPACKAGING</p><p>SYSTEM D:</p><p>SYSTEM E: </p><p>WEIGHINGBLEND</p><p>FILMCOATINGCOMPRESS</p><p>BOTTLEPACKAGING</p><p>WEIGHING</p><p>GRANULATION</p><p>FB DRY</p><p>MILLING</p><p>BLEND</p><p>FILMCOATINGCOMPRESS</p><p>BOTTLEPACKAGING</p><p>SYSTEM C:</p><p>There(e.g. direct compression,Continuous processing)</p><p>Heree.g. Wet Granulation</p></li><li><p>Learningfromotherindustries: Change</p><p>16</p></li><li><p>Learningfromotherindustries: QualityandBusinessBenefit</p><p>FINANCIAL INVESTMENT ($)- Industry- Society</p><p>Knowledge</p><p>Capability(Robustness)</p><p>PERFORMANCE-Cost, Quality, Time</p><p>FINANCIAL RETURNS ($)- Industry- Society</p><p>GRANULATIONMILLING</p><p>GRANULATIONMILLING</p><p>GRANULATIONMILLING</p><p>System</p><p>LEVERAGES- New Products (Strategic)- Existing Products (Tactical)</p><p>Knowledge</p></li><li><p>OUTLINE</p><p> Background ICHQ10 LookingatOtherIndustries</p><p>General Specific</p><p> Summary18</p></li><li><p>Learningfromotherindustries: MaturityModels</p><p> General QualityManagementMaturity(Crosby) PeopleMaturityModel BusinessProcessMaturityModel ISO9004</p><p> Specific CapabilityMaturityModel</p><p>19</p></li><li><p>Learningfromotherindustries: SigmaLevel&amp;CostofQuality</p><p>20</p><p>Pharma/Biotech</p><p>Semicon</p><p> Red Zone Products Have 25% COQ% Improvement Opportunity Yellow Zone Products Have 10% COQ% Improvement Opportunity Green Zone Can Capture Opportunity Now</p></li><li><p>Learningfromotherindustries: IndustrySpecificModel</p><p> General ISO9001:2008</p><p> IndustrySpecific TickIT TickITPlus CMMi</p><p>21</p></li><li><p>Learningfromotherindustries: ProcessMaturityandProductQuality:</p><p> SOFTWARE</p><p>22</p><p>DefectDensity</p><p>Process MaturityReference:CaperJones,SoftwareAssessment,Benchmarks&amp;BestPractices</p><p>DefectDensitymeasuredintermsof#defects/functionpoint</p></li><li><p>Learningfromotherindustries: ProcessMaturityandCostofQuality:</p><p> SOFTWARE:Knox(1993)</p><p>230 </p><p>10 </p><p>20 </p><p>30 </p><p>40 </p><p>50 </p><p>60 </p><p>Cos</p><p>t as </p><p>a P</p><p>erce</p><p>nt o</p><p>f Dev</p><p>elop</p><p>men</p><p>t</p><p>1 2 3 4 5 SEI CMM Level</p><p>Prevention Appraisal Int Failure Ext Failure TCoSQ</p></li><li><p>Learningfromotherindustries: QualityandOtherMeasuresof Performance</p><p> SOFTWARE:SoftwareEnterpriseInstitute(2006)</p><p>24</p></li><li><p>OUTLINE</p><p> Background ICHQ10 LookingatOtherIndustries</p><p>General Specific</p><p> Summary25</p></li><li><p>SUMMARY</p><p> OurQualitySystemsmustenablemoreofthekindand extentoflifecycleimprovementandinnovationwe</p><p> needandseek Q10isasignificantstepinthatdirection Additionallevelofgranularitycanhelptobuildonit Learningfromotherindustriescanhelpusdothat</p><p>26</p><p>Learning From Other IndustriesOUTLINETHE ECONOMIST: August 31st 2002Pharmaceuticals: Trouble in the makingThe Wall Street Journal: September 3rd 2003New Prescription For Drug Makers: Update the Plants The Wall Street Journal: September 3rd 2003New Prescription For Drug Makers: Update the Plants OUTLINEICH Q10ICH Q10OUTLINEQUALITYQUALITYLearning from other industries:Quality PhilosophiesLearning from other industries:W. Edwards DemingLearning from other industries:Focus and Cost of QualityLearning from other industries:Process MaturityLearning from other industries:ChangeLearning from other industries:Quality and Business BenefitOUTLINELearning from other industries:Maturity ModelsLearning from other industries:Sigma Level &amp; Cost of QualityLearning from other industries:Industry Specific ModelLearning from other industries:Process Maturity and Product Quality:SOFTWARELearning from other industries:Process Maturity and Cost of Quality:SOFTWARE: Knox (1993)Learning from other industries:Quality and Other Measures of PerformanceSOFTWARE: Software Enterprise Institute (2006)OUTLINESUMMARY</p></li></ul>