研发流程与简介.ppt

原料药工艺研发流程与QbD 技术转化为价值GMP – 医药化工法规约束稳定的工艺 – 实施GMP的基础QbD(质量源于设计）- 工艺开发指导 法规符合 Quality by Design质量源于设计 – 前控制质量源于生产 – 过程控制质量源于检测 – 后控制 法规符合 Quality by Design质量源于设计 Definition 定义 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. 以合理的科学和质量风险管理为依据的，起始于预定的质量目标，注重对产品和工艺的理解以及对生产工艺过程控制的系统的研发方法 Reference: ICH Q8(R)(2) Pharmaceutical Development, 2009 4 法规符合 What is Quality by Design ?什么是质量源于设计 (Reference: ICH Q8 (R2), 2009) 法规符合 Goals of Implementing QbD应用质量源于设计的目的 Achieve meaningful product specifications that are based on clinical performance. 根据临床需求建立有意义的产品质量标准 Reduce product variability and detects by increasing product and process understanding 通过对产品和其工艺的理解，减少产品质量的变异和瑕疵 Enhance product development and manufacturing efficiencies 提高产品开发和生产效率 Improve post-approval change management 改善和方便批准后更改的管理 7 QbD 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 Strategy 控制策略 Continual Improvement 继续改进 Systematic Approach by QbD Predefined Objective 预定的目标 Defined Quality Target Product Profile (QTPP) Identify Critical Quality Attributes (CQA) Product and Process Understanding 对产品和工艺的理解 Define Critical Material Attributes (CMA) Identify Critical Process parameters (CPP) Understanding the relationship between CMA, CPP and CQA Process Control 生产工艺过程控制 Establish appropriate control strategy Define Proven Acceptable Range (PAR) and Operational Range (OR) Sound Science 合理的科学 Literature Prior knowledge Development study Quality Risk Management 质量风险管理 Risk based approach through development to commercial manufacturing, as well as continual improvement Overview of QbD质量源于设计的概括 法规符合 Process Comparison 工艺比较 1 QbD Concept Approach Traditional Approach QTPP/CQA 2 Pr