下游工艺开发中质量源于设计(QbD)和纯化工艺的验证.pdfVIP

下游工艺开发中质量源于设 计(QbD)和纯化工艺的验证 Liu Jing jingliu@ Product support manager GE Healthcare Life Sciences 质量源于设计 Quality by design - 有效过程开发的框架 2 GE Title or job number 5/30/2013 什么是质量源于设计(QbD) Definition – “A systematic approach to development that begins with predefined objectives and emphasizes product and process understanding and