| 新版GMP中质量风险管理实施初探 |
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| 引用本文： | 徐勇,杨悦.新版GMP中质量风险管理实施初探[J].中国执业药师,2011,8(7):46-47,51. |
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| 作者姓名： | 徐勇 杨悦 |
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| 作者单位： | 1. 沈阳药科大学,辽宁,沈阳,110016;深圳致君制药有限公司,广东,深圳,518110
2. 沈阳药科大学,辽宁,沈阳,110016 |
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| 摘 要： | 目的:为制药企业质量管理发展方向提供建议。方法:总结新版GMP实施后对于企业的影响,分析我国药品生产质量管理的发展趋势。结果和结论:建议药品监管部门和药品生产企业未雨绸缪,以发展的眼光尽早地采用基于风险的质量管理方法。
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| 关 键 词： | 质量风险管理 生产质量管理规范 |
Primary Study on the Implementation of Quality Risk Management of GMP |
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| Authors: | Xu Yong Yang Yue |
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| Institution: | 1 Shenyang Pharmaceutical University, Liaoning Shenyang 110016, China; 2 Shenzhen Zhijun Pharmaceutical Co., Ltd., Guangdong Shenzhen 518110) |
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| Abstract: | To provide reference for the quality management of pharmaceutical companies, the impact of the implementation of newly published GMP was summarized and the trend of quality management of pharmaceutical manufacturing in China was analyzed. It is suggested that drug regulatory departments and pharmaceutical manufacturers prepare in advance and in the light of development adopt the risk-based quality management method. |
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| Keywords: | Quality Risk Management GMP |
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