| 药包材企业构建质量管理体系的研究 |
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| 引用本文： | 高用华,张军.药包材企业构建质量管理体系的研究[J].中国药事,2012,26(7):659-662. |
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| 作者姓名： | 高用华 张军 |
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| 作者单位： | 1. 中国医药包装协会,北京,100082
2. 江苏中金玛泰医药包装有限公司 |
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| 摘 要： | 目的 探讨如何在药包材生产企业构建质量管理体系,促进其管理水平的提升,从而提高产品质量,增强企业竞争力.方法 分析对比各种质量管理标准和法规的特点,以及针对药包材生产企业的适用性.结果与结论 药包材生产企业可以采用以ISO9001标准为纲领,以13号令(《直接接触药品的包装材料和容器管理办法》)为核心,以客户要求为补充,以2010版GMP为重要参考的立体构架模式,构建科学合理的药包材生产企业质量管理体系.
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| 关 键 词： | 药包材 质量管理体系 产品质量要求 体系架构 |
Quality Management System Building for Pharmaceutical Packaging Material Enterprises |
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| Gao Yonghua
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Zhang Jun.Quality Management System Building for Pharmaceutical Packaging Material Enterprises[J].Chinese Pharmaceutical Affairs,2012,26(7):659-662. |
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| Authors: | Gao Yonghua Zhang Jun |
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| Institution: | Gao Yonghua and Zhang Jun1(China Pharmaceutical Packaging Association,Beijing 100082;1Jiangsu Zhongjin Matai Medicine Packing Co.,Ltd.) |
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| Abstract: | Objective To explore how to build a quality management system in a pharmaceutical packaging material enterprise to promote its management and improve products’ quality,and therefore enhance competitiveness of the enterprise.Methods The characteristics of various quality management standards and regulations were analyzed to find out whether they were suitable for pharmaceutical packaging material enterprises.Results and Conclusion Pharmaceutical packaging material enterprises can build a scientific and rational quality management system based on ISO9001 standard,SFDA Decree No.13,customers’ requirements and GMP(2010 version). |
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| Keywords: | pharmaceutical packaging materials quality management system product quality requirement system building |
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