| 实施“质量源于设计”的五个关键因素 |
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| 引用本文： | 仲小燕,梁毅.实施“质量源于设计”的五个关键因素[J].机电信息,2011(23):14-17,45. |
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| 作者姓名： | 仲小燕 梁毅 |
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| 作者单位： | 中国药科大学医药产业发展研究中心,江苏南京,210009 |
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| 摘 要： | 介绍了工艺理解、设计空间、生产设计、工艺改进和工艺异常在＂质量源于设计＂中的作用,从人员合作、知识基础上阐述了实施QbD的关键因素。
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| 关 键 词： | 质量源于设计 QbD 设计空间 |
Five Critical Elements for Implementing Quality by Design |
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| Zhong Xiaoyan Liang Yi.Five Critical Elements for Implementing Quality by Design[J].Mechanical and Electrical Information,2011(23):14-17,45. |
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| Authors: | Zhong Xiaoyan Liang Yi |
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| Affiliation: | Zhong Xiaoyan Liang Yi (Research Centre of Pharmaceutical Industry Development,China Pharmaceutical University, Nanjing 210009,China) |
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| Abstract: | This paper introduces the roles of Process Understanding,Design Space, Design for Manufacturing,Process Improvement,Process Upsets in QbD and explains the five critical elements from aspects of collaboration and science basis. |
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| Keywords: | Quality by Design QbD Design Space |
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