PDA和全球制药工业(Robert-Dana)课件

PDA

ConnectingPeople,ScienceandRegulation®PDAandtheGlobalPharmaceuticalMarketPresentedatthe2011ParenteralDrugIndustryCongress,Beijing,ChinaSeptember2011PDAandtheGlobalPharmaceuticalMarketAboutPDATheGlobalPharmaceuticalMarketSummary4AgendaAboutPDAWhoarewe?OurVision,Mission&FocusOurActivitiesMemberCoreCompetenciesMemberBenefits5Weare:

Acommunityof9,500individualmemberscientistsandprofessionalsin70countriesrepresentinglargeandsmallpharmaceuticalandbiopharmaceuticalcompanies,regulatoryagencies,suppliersandacademia.6OurVision

Tobetheforemostglobalproviderofscience,technology,andregulatoryinformationandeducationforthepharmaceuticalandbiopharmaceuticalcommunity.7OurMissionTodevelopscientificallysound,practicaltechnicalinformationandresourcestoadvancescienceandregulationforthepharmaceuticalandbiopharmaceuticalindustrythroughtheexpertiseofourglobalmembership.8StrategicFocus

9OurActivities(Volunteers)Over1,000PDAvolunteersworldwideactivelycarryoutitsmission.PDAisaninfluentialvoiceandaleadingtechnicalorganizationinthefieldofpharmaceuticalscienceandtechnology.ThroughthedevelopmentofTechnicalReportsandresponsestoregulatoryinitiatives,PDAanditsmembersinfluencethefuturecourseofpharmaceutical/biopharmaceuticalproductstechnology.910IntheareasofScienceandTechnology,PDAinfluencesindustrydirection

DevelopspositionsoncurrentandproposedapplicationsoftechnologyRootedinscienceConsensusdrivenRepresentindustrybestpracticesIdentifiesandmonitorsnewtechnologiesOurActivities(SciTech)11SupportstheapplicationoftechnologyandcompliancerequirementsthroughmembershipparticipationScienceAdvisoryBoard(SAB)BiotechnologyAdvisoryBoard(BioAB)RegulatoryAffairsandQualityAdvisoryBoard(RAQAB)InterestGroups(IGs)TaskForces(TFs)OurActivities(SciTech)Cont.12PDAInterestGroupsarealignedtoAdvisoryBoardsInterestGroupsBIOABSABRAQABBiotechnologyBlowFillSealClinicalTrialMaterialsCombinationProductsFacilitiesandEngineeringInspectionTrendsLyophilizationFiltrationQualityRiskManagementPharmaceuticalColdChainMicrobiology/EMQualitySystemsVaccinesPackagingScienceRegulatoryAffairsPharmaceuticalWaterSystemsPrefilledSyringesProcessValidationSterileProcessingSupplyChainManagementTechnologyTransferVisualInspection1213OurActivities(TRs)TechnicalReportsMeantasrecommendation,andguidance,butarenon-prescriptive

However:MostreadanduseddocumentsbyregulatorsandindustryTRshaveinfluencedregulatoryGuidances,e.g.FDA’s2004AsepticGuideline,ISO13408-2andPIC/SAsepticGuide.NewTechnicalReports(2010and2011YeartoDate)TR47-PreparationofVirusSpikesUsedforVirusClearanceStudiesTR48-MoistHeatSterilizerSystems:Design,Commissioning,Operation,QualificationandMaintenanceTR49-PointstoConsiderforBiotechnologyCleaningValidationTR50-AlternativeMethodsforMycoplasmaTestingTR51-BiologicalIndicatorsforGasandVapor-PhaseDecontaminationProcesses:Specification,Manufacture,ControlandUseTR52-GuidanceforGoodDistributionPracticesforthePharmaceuticalSupplyChainTR53–GuidanceforIndustry:StabilityTestingtoSupportDistributionofNewDrugProducts15OurActivities

(Regulations)MonitorGlobalRegulatoryActivityPrimaryFocus:U.S.andEuropeanRegulatoryAgenciesIncludesICH,PIC/S,USP,EPandWHODevelopinginterestinAsiaandIndia

InfluenceGlobalRegulatoryPolicyInteractionswithglobalregulatoryauthoritiesCo-sponsormeetingswithRegulators(FDA,EMA,PIC/S,ICH)CommentsonproposedregulationsandguidancePromotescience-basedregulationsOurActivities(PCMOSM)16Scope UtilizingPDA’smembershipexpertisetodrive:theestablishmentof“bestpractice”documentstrainingeventsandcoursestoaidthepharmaceuticalmanufacturers’toimplementICHQ8,Q9andQ10IMPandcommercialproductsSeeourprojectdossieronthePDAwebsite(/pcmo)

formoreinformation17OurActivities(PCMOSM)Objectives

EnableaninnovativeenvironmentforcontinualimprovementofproductsandsystemsPutscienceintopracticeEnableincreaseofprocessrobustnessandknowledgeFosterrelieffromregulatoryprescriptionsPCMOProjectsLifecycleIMPmanufactureanddistributionImplementationofQbDinManufacturingTechnologyTransferSupplyChain/GoodDistributionPracticesQualitySystemsCapturingknowledgemanagementduringcommercialmanufacturingManagementofSuppliersandContractorsEstablishingaPharmaceuticalQualitySystemConceptsfortrainingAdditionalPCMOProjectsProcessFromProcessValidationtoProcessVerificationConceptsforCleaningValidationHowtoimproverobustnessofamanufacturingprocessUtilizationofstatisticalmethodsforproductionandbusinessprocessesCorrectiveandpreventiveactionsRiskManagementRiskBasedManufacturingSterileAPIsRisk-Basedschedulingofaudits20OurActivities(Conferences)World-classevents

Designedto

EducatePromoteinteractionAdvancememberinterestsGlobalvenuesScienceandRegulatoryfocus21OurActivities(TRI)State-of-the-arttrainingfacilityLearninginariskfreeenvironmentPDATraining&ResearchInstitute22TheTRICurriculum

ValidationLyophilizationPre-filledSyringesSterilizationTechnologyColdChainVisualInspectionAsepticProcessingBiotechnologyEnvironmentalMonitoringFiltrationMicrobiologyQuality/RegulatoryAffairsIncludescoursesin:23PDA’sStateoftheArtTrainingFacilityandRemoteCoursesBringConsistencyWorldwidePDAhasprovidedInspectorate

Trainingtoanumberofcountries Themostrecentare:RussiaKazakhstanEMAandmanyoftheEUInspectorate-Italy,UK,Ireland,Sweden,etc.USFDATraininghasbeenconductedinRussianandChineselanguagesOurActivities(Membership)MembershipcompetenciesMembershipbenefitsNewmembershipcategoryforemergingeconomies2425MembershipCoreCompetenciesAppliedSciencesAsepticProcessingManufacturingProcessEngineeringBiotechnologyMicrobiologyProcessValidation25QualityandRegulatoryRegulatory Compliance/GMPSupplyChainQualitySystems26MembershipBenefitsProfessionalResources&NetworkInterestGroupsTaskForcesChaptersCareerServiceCenterStudentScientificProgramsSci-TechDiscussionGroupOnlineMembershipDirectory27PublicationsPDAJournalofPharmaceuticalScience&TechnologyPDALetterTechnicalReportsBooksandScientificPublicationsMembershipBenefits(Cont.)28PDAJournalWebsiteJournalHighWirewebsitelaunchedin2009EasytouseandsearchArchivesbackto1998MorefeaturestocomeNewJournalEditorialStaffonboardRenewedemphasisoncorePDAmemberinterestsBiotech,Microbiology,AsepticProcessingandManufacturingarticlesdesiredNewReducedCostMembershipForemergingeconomies(includingChina)Electronicaccessto:PDAJournalwebsite,currentandprioryearPDALetterPDAmembershipdirectoryNoaccessto:ElectronicTechnicalReportsPrintversionofPDALetterAnnualCost:$100.00[canupgradetofullmembershipforadditional$149.00(total$249)]30SummaryPDAoffersauniquenetworkandplatformtoexchangeknowledgeandexperiencesPDAhasstrongrelationshipswithglobalregulatorsandstandardsettingorganizationsanditsTechnicalReportsarewelcomedPDAservestheindustrywithbyinfluencingscientific,technological®ulatorytrendsPDAistheorganizationforparenteralsTheGlobalPharmaceuticalMarketAgendaBusinessEnvironmentPharmaManufacturingEnvironmentRegulatoryEnvironmentClosingThoughts32BusinessChangesinPharmaDependenceonBlockbustersEmergingMarketsLossofPatentProtectionConsolidation/Mergers&Acquisitions33DependenceonBlockbusters34DiversificationviaGeographicExpansion

Emergingmarkets–shareofglobalpharmagrowth:

Source;IMSHealth35Patent“Cliff”36RecentPharmaMergersandAcquisitions37Processeshavebeenevolving…Frommortarandpestletohighlycomplexbioreactors.Frommanuallyintensiveasepticprocessestohighlyautomatedequipmentwithadvancedenvironmentalcontrols.FromtesttubestoRamanspectroscopy.FromPenandPapertoGigabytesofelectronicdata.38ThePharmaceuticalSupplyChainhasbecomemorecomplexGlobalizationofSupplyChainMoreoff-shoresourcinganddistributionIncreasedpercentageof“coldchain”productsIncreaseindiversion,counterfeitingand“economicallymotivatedadulteration”39Ourconceptofqualityhaschanged…FromtestandreleasetoQualityAssurancetoQualitybyDesign.From‘craftmanship’tovalidatedprocesses.FromR&D/Manufacturing/QualitysilostoQualitySystemApproachthatreachesfrombeginningofnewproductsthroughoutthelifecycle.40Ourregulatoryframeworkhasalsochanged…30yearsago:Highlyfragmented,lackofconsistency,20yearsago:BeginningsofEUintegrationandinternationalharmonization.TodayAdvancesinInternationalHarmonizationTomorrowGreatercooperationandexchangeofinformationamongglobalregulators41ChallengesforthePharmaceuticalIndustryinthe21stCenturyGlobalizationRationalizationIntegrationCostReductionSupplyChainIntegrityAlladduptoincreasedComplexity42GlobalizationRationalizationofManufacturingcapacityisoccurringatthesametimethatglobaldemandforpharmaceuticalsisrising.Growthrateismostnoticeablein“pharmerging”marketsChina,Brazil,Mexico,SouthKorea,India,TurkeyandRussiavs.US/EU/JapanCostpressuresaredrivingmoremanufacturingto“pharmerging”countries43RationalizationPharmamanufacturinghasover-capacityReductionoffacilitiesisongoingImpactisgreatestinUSandEuropeProductrationalizationisongoingatmajorpharma44IntegrationIntegratingmergerpartnersIntegratingCROsandCMOsIntegratingSuppliersAPIsExcipientsPackagingComponentsKeyManufacturingmaterials45CostReductionDeclineintop-linerevenueaddspressureonPharmacompaniestoreduceexpensestomaintainbottomlinerevenueRationalizationofovercapacityPricingpressureonmaterialsandCostofGoodsGovernmentpricingpressureisincreasingworldwide46SupplyChainIntegrityEnhancingSupplierQualityManagementsupplierselectionandqualificationprocesses,on-goingmonitoringandmanagement.IncreasingSupplyChainControlsforincomingmaterialsandcomp