| 新版GMP关于强化药品生产企业质量管理体系的探讨 |
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| 引用本文： | 杨敏茹,张荣玉. 新版GMP关于强化药品生产企业质量管理体系的探讨[J]. 西北药学杂志, 2011, 26(5): 377-378. DOI: 10.3969/j.issn.1004-2407.2011.05.028 |
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| 作者姓名： | 杨敏茹 张荣玉 |
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| 作者单位： | 陕西省新药审评中心,陕西西安,710065 |
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| 摘 要： | 目的介绍新修订GMP中增加的有关质量管理章节内容,对新版GMP中关于强化药品生产企业质量管理体系进行探讨。方法采用调查、归纳等方法,与新版GMP要求进行对比,阐述制药企业健全质量管理体系的组织、人员及培训要求;针对目前实际,对制药企业在产品质量风险评估、质量回顾分析等方面存在的差距予以剖析。结果为企业完善质量管理体系提出建议,使新版GMP要求尽快得到实施。结论完善药品生产质量管理体系,才能保证整个药品生产和使用过程安全有效。
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| 关 键 词： | 药品 GMP 质量管理 |
Discussion on the new GMP's content of improving quality management system in pharmaceutical enterprises |
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| YANG Minru,ZHANG Rongyu. Discussion on the new GMP's content of improving quality management system in pharmaceutical enterprises[J]. Northwest Pharmaceutical Journal, 2011, 26(5): 377-378. DOI: 10.3969/j.issn.1004-2407.2011.05.028 |
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| Authors: | YANG Minru ZHANG Rongyu |
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| Affiliation: | YANG Minru,ZHANG Rongyu(New Drug Approval Center of Shaanxi Province,Shaanxi Xi'an 710065,China) |
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| Abstract: | Objective To introduce the content of quality management in newly revised GMP and to discuss the content of pharmaceutical enterprise's quality management system.Methods The newly revised GMP,such as investigation,induction,building organizations,personnel and relevant trainings in the process of improving pharmaceutical enterprise's quality management system were compared and discussed.Results Some advises put forward to improve the quality management system.Conclusion Only improvement the quality manageme... |
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| Keywords: | drugs GMP quality management |
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