| 制药GMP质量体系有效性评价的模糊综合评价方法 |
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| 引用本文： | 陈霖,郑建国.制药GMP质量体系有效性评价的模糊综合评价方法[J].广西科学院学报,2011,27(4):311-313. |
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| 作者姓名： | 陈霖 郑建国 |
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| 作者单位： | 东华大学旭日工商管理学院;贝尔香精香料(上海)有限公司 |
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| 摘 要： | 提出药品生产质量管理规范（简称GMP）质量体系有效性评价的模糊综合评价方法,并运用该方法对1个制药公司的GMP质量体系的有效性进行实际测评分析。模糊综合评价方法运用模糊数学理论,从质量方针和目标、产品质量的稳定性、质量改进与创新、资源管理4个方面来综合评价制药GMP质量体系运行的有效性,评价结果具有整体性。
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| 关 键 词： | 评价方法 模糊综合评价 GMP 质量体系 有效性 |
| 收稿时间： | 2011/4/19 0:00:00 |
| 修稿时间： | 2011/8/24 0:00:00 |
Fuzzy Comprehensive Evaluation Method for the Evaluation of Pharmaceutical GMP Quality System Effectiveness |
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| CHEN Lin and ZHENG Jian-guo.Fuzzy Comprehensive Evaluation Method for the Evaluation of Pharmaceutical GMP Quality System Effectiveness[J].Journal of Guangxi Academy of Sciences,2011,27(4):311-313. |
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| Authors: | CHEN Lin and ZHENG Jian-guo |
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| Institution: | 1 (1.Glorious Sun School of Business and Management,Donghua University,Shanghai,200051,China;2.Bell Flavors & Fragrances(Shanghai) Inc.,Shanghai,201615,China) |
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| Abstract: | A fuzzy comprehensive evaluation system was proposed and it was used to evaluate the effectiveness of the GMP quality system of a pharmaceutical company.The system was established to evaluate the effectiveness of GMP quality system using a fuzzy mathematics theory based on the policy and goal of quality,stability of the product’s quality,quality improvement and innovation,and resource management.The evaluation system provided a complete algorithm for the GMP quality system evaluation process. |
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| Keywords: | evaluation method fuzzy comprehensive evaluation GMP quality system effectiveness |
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