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...
