研发流程与QbD简介DS课件.pptVIP

研发流程与QbD简介DS;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;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;Quality by Design质量源于设计;What is Quality by Design ?什么是质量源于设计 (Reference: ICH Q8 (R2), 2009);Goals of Implementing QbD应用质量源于设计的目的;QbD Terminology ;Systematic Approach by QbD;Overview of QbD质量源于设计的概括; Process Comparison 工艺比较;Process Development Procedure - 产品开发流程;Example  Identify CQA in Drug Substance;Quality Risk Management Process;Risk Assessment Tools风险评估的工具;Selected Tools Used in the Risk Assessment 用于风险评估的工具举例;Ishikawa (Fishbone) Diagrams;Failure Mode Effects Analysis (FMEA);Critical Quality Attribute (right) ? ? ?;Design Space 设计空间;Design Space 设计空间 ;Important Note;Control Strategy控制策略;Control Strategy控制策略;Critical Quality Attribute (right) ? ? ?;Critical Quality Control Strategy of Drug Substance;Process Development Report工艺硏发报吿 ;Process Development Report工艺硏发报吿 ;Process Development Report工艺硏发报吿 ;1. Introduction: Drug Substance – Identity and Attributes 2. Synthetic Route Development – Evaluation 3. Potential Quality Attributes of the Drug Substance 4. Preliminary Risk Assessment for Critical Quality Attributes 5. Starting Material Discussion 6. Optimization of Manufacturing Process 7. Manufacturing 7.1. Brief Description 7.2. Synthetic Scheme 7.3. Detailed Description of the Process Control 8. Critical Quality Control Strategy of Drug Substance 9. History of Manufacturing Process;Attachments: ? Supplier Specifications for Starting Material Specifications for Starting Material and Intermediates Process Control Map – Detailed Risk Assessment C of A Summary of Manufactured Batches Glossary of Abbreviations;QbD - 产品开发流程 – 工艺开发报告 比较;Quality by Design质量源于设计目标：设计和开发的工艺能够在可控风险的情况下生产出符合质量标准的产品满足产品??量要求的工艺开发是执行GMP全过程的基础 - 全程可控