拜耳-在线质量分析.pdf

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1、Qualitybydesign:AddinginnovativeProcessAnalyzerTechnologytoyourmanufacturingprocess质量源于设计:将创新过程分析技术应用于生产工艺BTES-TS-PAT,Ms.XiangYuProcess,June2010制药行业–现实的问题zUtilizationlevels-15%orless(butlowlevelsmasked).利用率–小于15%(但这种低利用率被隐藏了).zScrapandrework-weplanfor5-10%(acceptedasn

2、ecessary).报废和重新生产–估计5-10%(有必要接受的).zTimetoeffectiveness-takesyears(notchallenged).有效时间–数年(无需质疑).zCostsofquality-inexcessof20%(that'sthewayitis).品质控制的成本–超过20%(情况如此).QbD:AddinginnovativePATtoyourmanufacturingprocessBTES-TS-PAT;Ms.XiangYu2010-06-02•Page2举例:典型的制药工艺时间35天!10

3、0%Packaging包装CoatingConversionCost包衣转化所需成本Comp压缩Gran.分散造粒.Disp.0%3daysTime时间35daysQbD:AddinginnovativePATtoyourmanufacturingprocessBTES-TS-PAT;Ms.XiangYu2010-06-02•Page3调查表明有改进的潜力100%Costreduction降低成本TimeCompression缩短时间0%3days35daysQbD:AddinginnovativePATtoyourmanufac

4、turingprocessBTES-TS-PAT;Ms.XiangYu2010-06-02•Page4制造质量High高66556σ-WorldClass世界级5σ-Superior优级QUALITY444σ-Healthy健康的质量3σ-Average平均水平332σ-NotCapable不达标的1σ-NotCompetitive完全无竞争力的2211Low低LowHigh高PRODUCTIVITY产量QbD:AddinginnovativePATtoyourmanufacturingprocessBTES-TS-PAT;Ms.

5、XiangYu2010-06-02•Page5http://www.fda.gov/cder/guidance/6419fnl.pdfProcessAnalyticalTechnologyProcessAnalyticalTechnology(PAT):(PAT):WhatWhat抯抯inaname?inaname?D.ChristopherWatts,Ph.D.D.ChristopherWatts,Ph.D.OfficeofPharmaceuticalScience,CDER,FDAOfficeofPharmaceuticalS

6、cience,CDER,FDAScienceSeminarSeriesfortheOfficeofCommissionerQbD:AddinginnovativePATtoyourmanufacturingprocessBTES-TS-PAT;Ms.XiangYu2010-06-02•Page6April9,2004April9,2004PATPATApproach:QualitybyDesignApproach:QualitybyDesign质量从设计开始聚焦于工艺的理解(=PAT)•哪些参数是决定产品质量的关键？–根据实验设计

7、•如何监控，分析这些参数？–运用合适的仪表使其直观化•如何控制这些贯穿整个工艺的参数？QbD:AddinginnovativePATtoyourmanufacturingprocessRef.:C.Watts,FDACDERBTES-TS-PAT;Ms.XiangYuhttp://www.fda.gov/cder/OPS/PATCommissionerSem2004.ppt2010-06-02•Page7CurrentcontrolphilosophyCurrentcontrolphilosophy现有控制理念Processcon

8、trolPolicingfunction监察功能过程控制Off-line(lab-based)离线(基于实验结果)Closedloopcontrol闭合回路控制reviewofproductqualityparameters(processpara