顾博士GenericDrug_CMCRequirement_2012Nov1资料.ppt

Quality by Design (QbD)质量源于设计 Definition Systematic approach to development that begins with predefined objectives and emphasizes product and process understanding and process control, based on sound science and quality risk management. 应用合理的科学方法和质量风险管理原则，始于预定产品质量的目标，着重于对产品和工艺的理解以及工艺控制的系统性的研究和开发方法。 Reference: ICH Q8(R)(2) Pharmaceutical Development, 2009 * * Quality by Design质量源于设计 Terminology Quality Target Product Profile 目标产品质量概况 Critical Quality Attributes 关键质量属性 Critical Material Attributes 关键物料属性 Critical Process Parameters 关键工艺参数 Risk Assessment 风险评估 Design Space 设计空间 Control Strate