探讨质量源于设计 (QbD)理念 ,提升分析方法开发 ,检证和转移水准分享学习QbD 的体会; 抛砖引玉, 使各位对于QbD 如何结合工作实践带来一些有益地思考了解QbD 的定义和基本概念初步建立QbD 理念是如何融入分析方法开发- 验证/ 转 移不渉及必须遵守规则性(SOP), 和具体应用实践细节讲课目的www.ICH.org “Quality can not be tested into products; it has to be built in by design”Jospeh M Juran产品质量不是被测试出来的, 质量必须被设计进产品。Quality By Design QbDQbD is defined as “a systematic approach to development that begins with predefined objectives and emphasises product and process understanding based on sound science and quality risk management”定义: 用
