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PDA技术报告清单2015

上传者:随心@流浪 |  格式:docx  |  页数:7 |  大小:22KB

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012 生物制品的分析方法验证和转移,201258.RiskManagementforTemperature-ControlledDistribution2012温度受控销售风险管理,201259.UtilizationofStatisticalMethodsforProductionMonitoring2012生产监测用统计学方法使用,201260.ProcessValidation:ALifecycleApproach2013 工艺验证:生命周期方法,201361.SteamInPlace2013 就地蒸汽,201362.mendedPracticesforManualAsepticProcesses2013人工无菌工艺规范建议,201363.QualityRequirementsfortheExtemporaneousPreparationofClinicalTrial2013临床试验临时制备药物的质量要求,201364.ActiveTemperature-ControlledSystems:QualificationGuidance2013 在用温度控制系统:确认指南,201365.TechnologyTransfer2014 技术转移,201466.ApplicationofSingle-UseSystemsinPharmaceuticalManufacturing2014 药物生产中单次使用系统的应用,201467.anismsfromNonsterilePharmaceuticals,MedicalDevices,andCosmetics2014非无菌药物、医疗器械和化妆品中致病菌排除201468.Risk-BasedApproachforPreventionandManagementofDrugShortages2014基于风险的药品存贮预防和管理,2014

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