产品质量全寿命周期实施-引言

ISPE-CCPIECHINACONFERENCE2008Nov11-122008BeijingPQLI(ProductQualityLifecycleImplementation)-Introduction–QiangZheng,PhDCenterforPharmaceuticalInformationandEngineeringResearchPekingUniversityISPE-CCPIECHINACONFERENCE2008ICHQualityGuidancesQ8:PharmaceuticalDevelopment(QualitybyDesignQbD)QbDQ9:RiskManagementQ10:PharmaceuticalQualitySystem(Q11):DevelopmentandManufacturingofDrugSubstanceISPE-CCPIECHINACONFERENCE2008Q8Q9Q10&Q11vs.PQLIvs.ISPEICHPQLIISPEPQLItoprovideapracticalgloballyacceptableapproachtoimplementQ8Q9Q10andQ11guidancesPQLIICHPQLItoprovidetechnicalframeworktobecomecrossfunctionaltoolsvaluedbyboththeindustryandregulatoryauthoritiesworldwidePQLIPQLIstartedbyISPEinJune2007,withsupportfromICHandtheindustryPQLIISPE20076,ISPE-CCPIECHINACONFERENCE2008China’sNeedEstablishapharmaceuticalqualitymanagementsystemcompatibletointernationalstandards,toeffectivelyreducethequalityrelatedsafetyrisks,andtobroadlyraisethequalityprofileofChina’smedicinalproductsPQLI)Followthelatestinternationaldevelopmentofpharmaceuticalqualityrelatedregulationandscienceandtechnology,andconductresearchonthepharmaceuticalqualitymanagementsystem(PQLI)Effectivelyimplementthepre-approvalinspection(PAI)toensurepharmaceuticalqualitybyimprovingprocessdevelopmentandverification(QbD)ISPE-CCPIECHINACONFERENCE2008ISPEChinaMr.D’EramoISPEPaulFrom2005to2006,ISPEco-sponsoredthefirsttwoofficialFDAcGMPChinaTrainingWorkshops(withtheUSFDA,PKUandCCPIE),andthefirstofficialEU-SwissmedicGMPChinaWorkshop(withtheEMEAandSwissmedicandPKU)20052006ISPEFDAFDAcGMPGMPMr.PaulD’EramoofficiallyrepresentedISPEanddeliveredlecturestoallthreeaboveworkshops,andwastheonlyspeakerattendingallthreeworkshops·ISPE3Mr.PaulD’EramowasformallyUSFDA’sGMPinspector,formerChairmanofISPE,andcurrentlyExecutiveDirectorQualityandComplianceWorldwide,J&JFDAGMPISPEJ&JISPE-CCPIECHINACONFERENCE2008Let’swelcomeMr.PaulD’EramotospeakonPQLIandQbD·PQLIQbDISPE-CCPIECHINACONFERENCE2008Nov11-122008BeijingProductQualityLifecycleImplementationQualitybyDesignProductQualityLifecycleImplementationQualitybyDesignPaulD’EramoExecutiveDirectorQuality&ComplianceWorldwideJohnson&JohnsonISPE-CCPIECHINACONFERENCE2008TheImportanceofICH–Anewvisionforensuringproductquality•InternationalConferenceonHarmonisation(ICH)•Contributorsfromindustry®ulatoryauthorities,EU,USandJapan•Industry-EFPIA,PhRMA,JPMA•Regulators–EMEA,FDA,MHLW•Importanceofrecent3ICHdocuments•Q8–PharmaceuticalDevelopment•Q9–RiskManagement•Q10–PharmaceuticalQualitySystems(PQS)ISPE-CCPIECHINACONFERENCE2008•ReducedFilingRequirementsforProcessChanges•Fewersupplementsandfasterapprovals•Greateropportunityforprocessimprovements•BusinessOpportunities(Therealfocus)•Improvedprocesscapability•Reducedcycletime•Real-time-release•Reducedfailureandinvestigationcost•Increasedyields•Greaterpredictabilityallowingforleanimplementation•ReducedinventoryOpportunitiesISPE-CCPIECHINACONFERENCE2008MerckGetsApprovalforReal-time-release•SolidDosageForm•Immediate-releasefilm-coatedtablet•Highlysolubledrugsubstance•Directcompressionprocess•Approvedin61countries•ReducedManufacturingCost•97%reductioninanalysttime•11.2hrsto0.3hrs•43%reductionincycletime•7daysto4daysFebruary2008ISPE-CCPIECHINACONFERENCE2008ScopeofISPE’sPQLI•WorkwithindustryandregulatoryleadersworldwidetodeveloppragmaticandpracticalimplementationofICHguidancesbasedonsoundscientific,engineeringandbusinessprinciples•Notregulatorydocuments•Industrylead•Emphasison“howto”ICHQ-8-9-10•Focuson3ICHRegions;considerothersISPE-CCPIECHINACONFERENCE2008PQLI–VariousPresentations&Publications•Arlington–June2007•Berlin–September2007•LasVegas–October2007•Singapore(PIC/S)–November2007•London(FIP)–November2007•Baltimore(IFPAC)–January2008•Copenhagen–9-11April2008•Tokyo–17-18Apr2008•BocaRaton,FL–October2008•GoldSheet–January2008•EuropeanPharmaceuticalReview-February2008ISPE-CCPIECHINACONFERENCE2008PQLITopicAreas&TeamLeads•Criticality•TomSchultz,J&J•RogerNosal,Pfizer•ControlStrategy•BruceDavis,AZ•LineLundsberg,NNEPharmaplan•DesignSpace•JimSpavins,Pfizer•JohnLepore,Merck•LegacyProducts•ChrisPotterISPE-CCPIECHINACONFERENCE2008PQLITaskTeams’Membership•International•Largeandsmallpharma,&suppliers•Engineers&scientists•Startedwithsmallmolecule,butwillembracebiotech•Outputs•Engagement&debate•Useofcasestudies•Whitepapers&articles•e.g.JPI(JournalofPharmaceuticalInnovation)•FreeJPIPQLIarticlesonISPEwebsiteISPE-CCPIECHINACONFERENCE2008ISPEJournalofPharmaceuticalInnovation(JPI)•Juneissue•Articles•Keytopics•Controlstrategy•Criticality•DesignspaceISPE-CCPIECHINACONFERENCE2008Diagramtolinkfirst3teamsKnowledgeSpaceincludingCriticalityAnalysisDesignSpacebasedonKnowledgeSpaceControlStrategyKnowledgeSpaceDesignSpaceNormalOperatingRangesISPE-CCPIECHINACONFERENCE2008Team1–CriticalitySomeunderstanding/comments•Amaterial,processattributeorparameterthatisdesignatedascriticalhasadirectorindirectimpactonpatientsafety,efficacy,compliance&productmanufacturabilityforwhichfailuretocontrolwithindemonstrableacceptancecriteriaproducesanunrecoverableresult•Acontrolstrategyortest