| 引用本文： |
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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. [点击复制]
- CHEN Lin,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. [点击复制]
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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。 |
| 关键词: 评价方法 模糊综合评价 GMP 质量体系 有效性 |
| DOI： |
| 投稿时间：2011-04-19修订日期：2011-08-24 |
| 基金项目: |
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| Fuzzy Comprehensive Evaluation Method for the Evaluation of Pharmaceutical GMP Quality System Effectiveness |
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CHEN Lin1,2, ZHENG Jian-guo1
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| (1.Glorious Sun School of Business and Management, Donghua University, Shanghai, 200051, China;2.Bell Flavors & Fragrances(Shanghai) Inc., Shanghai, 201615, China) |
| 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. |
| Key words: evaluation method fuzzy comprehensive evaluation GMP quality system effectiveness |
