ICH-Q11-原料药开发与制造-中英对照

ICHQ11原料药开发和制造中英对照Page1of45DEVELOPMENTANDMANUFACTUREOFDRUGSUBSTANCES(CHEMICALENTITIESANDBIOTECHNOLOGICAL/BIOLOGICALENTITIES)Q11CurrentStep4versiondated1May2012TABLEOFCONTENTS1.Introduction介绍...................................................................................................................................................32.Scope范围.............................................................................................................................................................43.ManufacturingProcessDevelopment制造工艺开发...........................................................................................43.1GeneralPrinciples总则...............................................................................................................................43.1.1DrugSubstanceQualityLinktoDrugProduct原料药质量与制剂产品的联系............................43.1.2ProcessDevelopmentTools工艺开发工具.....................................................................................53.1.3ApproachestoDevelopment开发方法............................................................................................53.1.4DrugSubstanceCriticalQualityAttributes原料药关键质量属性（CQA）.................................73.1.5LinkingMaterialAttributesandProcessParameterstoDrugSubstanceCQAs物料属性及工艺参数与原料药关键质量属性的联系............................................................................................................83.1.6DesignSpace设计空间..................................................................................................................103.2SubmissionofManufacturingProcessDevelopmentInformation制造工艺开发信息的申报................123.2.1OverallProcessDevelopmentSummary全面工艺开发总结........................................................123.2.2DrugSubstanceCQAs原料药的关键质量属性...........................................................................133.2.3ManufacturingProcessHistory制造工艺历史..............................................................................133.2.4ManufacturingDevelopmentStudies制造开发研究.....................................................................144.DescriptionofManufacturingProcessandProcessControls制造工艺描述与工艺控制.................................155.SelectionofStartingMaterialsandSourceMaterials起始物料筛选及物料来源.............................................165.1GeneralPrinciples总则.............................................................................................................................165.1.1SelectionofStartingMaterialsforSyntheticDrugSubstances化学合成原料药起始物料的筛选.................................................................................................................................................................165.1.2SelectionofStartingMaterialsforSemi-SyntheticDrugSubstances半合成原料药起始物料的筛选.............................................................................................................................................................185.1.3SelectionofSourceandStartingMaterialsforBiotechnological/BiologicalDrugSubstances生物技术/生物制品起始物料的选择.............................................................................................................185.2SubmissionofInformationforStartingMaterialorSourceMaterial起始物料或物料来源的信息申报195.2.1JustificationofStartingMaterialSelectionforSyntheticDrugSubstances合成原料药起始物料的选择依据.................................................................................................................................................195.2.2JustificationofStartingMaterialSelectionforSemi-SyntheticDrugSubstances半合成原料药起始物料的选择依据..................................................................................................................................205.2.3QualificationofSourceorStartingMaterialsforBiotechnological/BiologicalDrugSubstances生物技术/生物制品原料药源物料或起始物料源物料的确认.................................................................206.ControlStrategy控制策略..................................................................................................................................216.1GeneralPrinciples总则.............................................................................................................................21ICHQ11原料药开发和制造中英对照Page2of456.1.1ApproachestoDevelopingaControlStrategy开发控制策略的方法...........................................216.1.2ConsiderationsinDevelopingaControlStrategy开发控制策略的考虑事项..............................226.2SubmissionofControlStrategyInformation控制策略信息的申报........................................................237.ProcessValidation/Evaluation工艺验证/评价....................................................................................................247.1GeneralPrinciples总则.............................................................................................................................247.2PrinciplesSpecifictoBiotechnological/BiologicalDrugSubstance生物技术/生物制品原料药的特殊原则.....................................................................................................................................................................258.SubmissionofMan