制药行业发展趋势(博世) 35页

'BoschPharmaIn-houseshowHangzhou2014博世制药研讨会杭州2014TrendsinthePharmaceuticalIndustry制药行业发展趋势MartinGrossGeneralManager HüttlinGmbHABoschPackagingCompany GermanyPackagingTechnology 1Confidential|PADH/GM|27/01/2014|©RobertBoschGmbH2014.Allrightsreserved,alsoregardinganydisposal,exploitation,reproduction,editing,distribution,aswellasintheeventofapplicationsforindustrialpropertyrights. TrendsinthePharmaceuticalIndustry制药行业发展趋势Generaltrends总体趋势èThesupplyoftheworldpopulationwithMedicineisbyfarnotsufficient. è目前对全球市场的药物供给仍处于短缺状态èGrowthofpopulationandwealthwillincreasethepressureinvolumeandcost è人口和财富的增长将对供应量和费用上产生压力èGenericswillgrowfurther è仿制药将进一步增加èGlobalisationleadstoaconsolidation(M&A)andstandardisationofthepharmaceuticalIndustryè全球化将引发制药行业的合并和标准化èResearchofNDwillbecomemoredifficultandexpensive è新药的研发将会愈加困难和昂贵èAnticounterfeitingwillbecomemoreandmoreimportant è防伪将越来越重要èThecombinationofrequirementslikeQualityatlowcostwilldrivenewtechnologies è综合需求如降低成本的前提下保证质量将催发新技术的出现èTheInternetwillincreasetheamountofinformationandknowlede è互联网将极大增加信息和知识量èSocialnetworksviaInternetwillexchangeinformationmuchmoreintenseandveryfast è基于互联网的社交媒体将引起更快更密集的信息交换 PackagingTechnology2Confidential|PADH/GM|27/01/2014|©RobertBoschGmbH2014.Allrightsreserved,alsoregardinganydisposal,exploitation,reproduction,editing,distribution,aswellasintheeventofapplicationsforindustrialpropertyrights. BoschPackagingTechnology–Pharma博世包装技术-制药Oursolutionsforsolidpharmaceuticalsmediasystems固体制药解决方案配液系统Capsulefilling胶囊填充granulationsystemtabletpressing压片tabletcoating包衣Inspection检测制粒系统Track&Trace追踪系统Secondary packaging二级包装PackagingTechnology3Confidential|PA-PH/MKT|27/01/2014|©RobertBoschGmbH2014.Allrightsreserved,alsoregardinganydisposal,exploitation,reproduction,editing,distribution,aswellasintheeventofapplicationsforindustrialpropertyrights. TrendsinthePharmaceuticalIndustry制药行业发展趋势QbD(Qualitybydesign)质量源于设计èChangefromQbTtoQbD从QbT向QbD改变QualitybyTesting(QbT)质量源于测试（QbT） QualitybyDesign(QbD)质量源于设计（QbD）PackagingTechnology4Confidential|PADH/GM|27/01/2014|©RobertBoschGmbH2014.Allrightsreserved,alsoregardinganydisposal,exploitation,reproduction,editing,distribution,aswellasintheeventofapplicationsforindustrialpropertyrights. TrendsinthePharmaceuticalIndustry制药行业发展趋势QbD(Qualitybydesign)质量源于设计èIncreaseknowledgeaboutprocesses,productsandequipment è不断增长的关于工艺，产品和设备的知识lCollaborationbetweenacademicsandsuppliers l学术机构和供应商的合作lStructuringandsecuringknowledgeindatabase l结构化和可靠的数据库lUsingsimulationsoftwarebasedondatabase l根据数据库创建的模拟软件èQbDstartsfromR+Ddowntomanufacturing èQbD贯穿研发到生产èQbDincludesScale-upissues èQbD也应用于放大实验PackagingTechnology 5Confidential|PADH/GM|27/01/2014|©RobertBoschGmbH2014.Allrightsreserved,alsoregardinganydisposal,exploitation,reproduction,editing,distribution,aswellasintheeventofapplicationsforindustrialpropertyrights. TrendsinthePharmaceuticalIndustry制药行业发展趋势ExampleQbDApproachQbD方法示例Productprofile产品信息.QualityTargetproductprofile(QTPP)产品信息质量目标CQAs关键质量参数.Determinecriticalqualityattributes(CQAs)确定关键质量参数Riskassessment风险评估.LinkrawmaterialattributesandprocessparameterstoCQAsandperformriskassessment将原材料特性和工艺参数和关键质量参数结合起来执行风险评估DesignSpace工程分析工具.Developadesignspace开发工程分析工具ControlStrategy控制策略.Designandimplementacontrolstartegy制定并执行控制策略CIP持续改进.Manageproductlifecycle,includingcontinualimprovement控制管理整个产品周期，包含持续改进 PackagingTechnology6Confidential|PADH/GM|27/01/2014|©RobertBoschGmbH2014.Allrightsreserved,alsoregardinganydisposal,exploitation,reproduction,editing,distribution,aswellasintheeventofapplicationsforindustrialpropertyrights. TrendsinthePharmaceuticalIndustry制药行业发展趋势PackagingTechnology 7Confidential|PADH/GM|27/01/2014|©RobertBoschGmbH2014.Allrightsreserved,alsoregardinganydisposal,exploitation,reproduction,editing,distribution,aswellasintheeventofapplicationsforindustrialpropertyrights. TrendsinthePharmaceuticalIndustry制药行业发展趋势PackagingTechnology 8Confidential|PADH/GM|27/01/2014|©RobertBoschGmbH2014.Allrightsreserved,alsoregardinganydisposal,exploitation,reproduction,editing,distribution,aswellasintheeventofapplicationsforindustrialpropertyrights. TrendsinthePharmaceuticalIndustry制药行业发展趋势HSErequirementsaregloballyincreasing全球对健康，安全，环境要求愈加提升èContainment密闭型lHighpotentAPIs高/强活性成分含量 lProductandoperatorsafety产品和操作人员安全 èAnholisticapproach整体方案lThecontainmentchapterofthedraftISPEBPCBaseline®Guide,issuedin2007,recommends l在2007年发布的ISPEBPCBaseline®Guide关于防护的章节中，建议了： lasimilarholisticapproachtothatadoptedforHSE,followingthestepsbelowinsequential ordertoalleviateanexposurepotentialwhereverpossible:类似于此的整体方案适用于HSE，需遵循以下步骤来尽可能的减轻暴露危险： PackagingTechnology9Confidential|PADH/GM|27/01/2014|©RobertBoschGmbH2014.Allrightsreserved,alsoregardinganydisposal,exploitation,reproduction,editing,distribution,aswellasintheeventofapplicationsforindustrialpropertyrights. TrendsinthePharmaceuticalIndustry制药行业发展趋势5OEL<1µm/m³<0,1mg/d4OEL<1-10µm/m³<0,1-1mg/d3OEL<10-100µm/m³<1-10mg/d2OEL<100-1000µm/m³<10-100mg/d1OEL<1000-5000µm/m³>100mg/dPackagingTechnology 10Confidential|PADH/GM|27/01/2014|©RobertBoschGmbH2014.Allrightsreserved,alsoregardinganydisposal,exploitation,reproduction,editing,distribution,aswellasintheeventofapplicationsforindustrialpropertyrights. TrendsinthePharmaceuticalIndustry制药行业发展趋势PackagingTechnology 11Confidential|PADH/GM|27/01/2014|©RobertBoschGmbH2014.Allrightsreserved,alsoregardinganydisposal,exploitation,reproduction,editing,distribution,aswellasintheeventofapplicationsforindustrialpropertyrights. TrendsinthePharmaceuticalIndustry制药行业发展趋势PackagingTechnology 12Confidential|PADH/GM|27/01/2014|©RobertBoschGmbH2014.Allrightsreserved,alsoregardinganydisposal,exploitation,reproduction,editing,distribution,aswellasintheeventofapplicationsforindustrialpropertyrights. TrendsinthePharmaceuticalIndustry制药行业发展趋势SMEPACTestatadockingportrearrightX32 (StandardizedMeasurementofEquipmentParticulateAirborneConcentration) 对接口X32SMEPAC测试PackagingTechnology 13Confidential|PADH/GM|27/01/2014|©RobertBoschGmbH2014.Allrightsreserved,alsoregardinganydisposal,exploitation,reproduction,editing,distribution,aswellasintheeventofapplicationsforindustrialpropertyrights. TrendsinthePharmaceuticalIndustry制药行业发展趋势PackagingTechnology 14Confidential|PADH/GM|27/01/2014|©RobertBoschGmbH2014.Allrightsreserved,alsoregardinganydisposal,exploitation,reproduction,editing,distribution,aswellasintheeventofapplicationsforindustrialpropertyrights. TrendsinthePharmaceuticalIndustry制药行业发展趋势HSEèExplosionprotection防爆lATEXèEnvironmentalprotection环境保护 èWastetreatment废物处理èWastewater废水èExhaustairfromprocessequipmentandrooms工艺设备和房间的排风 èFiltersystems过滤器系统èSolventabatementsystems溶剂含量降低系统PackagingTechnology 15Confidential|PADH/GM|27/01/2014|©RobertBoschGmbH2014.Allrightsreserved,alsoregardinganydisposal,exploitation,reproduction,editing,distribution,aswellasintheeventofapplicationsforindustrialpropertyrights. SafetySafetyconceptsATEXregulationsHighShearMixer湿法制粒机HTG/HBGWhyATEX?为什么要防爆？FluidBedTechnology流化床技术HD/HDG/HDGCDustclasses粉尘等级GranulationSuite制粒线HTG/HBG+HDGasclasses气体等级ATEXcertificationsATEX证书PackagingTechnology 16Confidential|Department|27/01/2014|©RobertBoschGmbH2014.Allrightsreserved,alsoregardinganydisposal,exploitation,reproduction,editing,distribution,aswellasintheeventofapplicationsforindustrialpropertyrights. TrendsinthePharmaceuticalIndustry制药行业发展趋势Internetandsocialmedia互联网和社交媒体èInternetofthings物联网èChancetocollectdata数据收集 ltrackandtracechain追踪系统链lsecuresupplychain安全供应链l….èSocialmediagettingmoreandmoreimportant社交媒体愈加重要lNewgenerationisgrowingup新一代的成长 lNetworkingofgroups团体的社交网络 lExchangingofexperience经验交换èhttp://boschpharma-blog.com/category/global-solid-dosage/PackagingTechnology 17Confidential|PADH/GM|27/01/2014|©RobertBoschGmbH2014.Allrightsreserved,alsoregardinganydisposal,exploitation,reproduction,editing,distribution,aswellasintheeventofapplicationsforindustrialpropertyrights. TrendsinthePharmaceuticalIndustry制药行业发展趋势PersonalizedMedicine定制化药品èBlockbustersvssmallvolumenicheproducts è重磅产品vs少量的孤儿产品èBothwillbethere两种产品都将存在lBlockbusters重磅产品lHighvolume高产量lIncreasingefficiency效能提高 lPressureoncost成本压力lSmallvolumenicheproducts少量的孤儿产品lRiskofquality质量风险lIncreasingdemandonautomation对自动化需求增加 lEnsuretherightproductreachestherightpatient确保正确的产 品用于正确的患者lTrackandtrace追踪系统 lGeriatrics老人病科 lPaediatrics儿科PackagingTechnology 18Confidential|PADH/GM|27/01/2014|©RobertBoschGmbH2014.Allrightsreserved,alsoregardinganydisposal,exploitation,reproduction,editing,distribution,aswellasintheeventofapplicationsforindustrialpropertyrights.'