| 我国制药企业人员资质与培训问题研究 |
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| 引用本文： | 林琳,李野,杨悦.我国制药企业人员资质与培训问题研究[J].中国药事,2009,23(12):1189-1192. |
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| 作者姓名： | 林琳 李野 杨悦 |
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| 作者单位： | 沈阳药科大学工商管理学院,沈阳,110016 |
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| 摘 要： | 目的规范我国制药企业人员的资质与培训内容。方法分析美国和欧盟与GMP人员资质和培训相关的法规文件,同我国GMP文件进行比较,查找我国制药企业人员素质的不足之处。结果与结论建立一套比较完整的GMP人员资质与培训管理体系,才能保证药品生产质量,真正为公众的用药安全负责。
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| 关 键 词： | GMP 资质 培训 |
The Study On The Personnel Qualification And Training Of Chinese Pharmaceutical Factory |
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| Lin Lin,Yang Yue,Li Ye.The Study On The Personnel Qualification And Training Of Chinese Pharmaceutical Factory[J].Chinese Pharmaceutical Affairs,2009,23(12):1189-1192. |
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| Authors: | Lin Lin Yang Yue Li Ye |
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| Institution: | ,Li Ye(College of Business Administration,Shenyang Pharmaceutical University,Shenyang110016) |
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| Abstract: | Objective To improve the personnel qualification and training of Chinese pharmaceutical factory.Methods Analyzing the related documents on the GMP personnel qualification and training of American and EMEA,comparing with our GMP regulations,study the FDA warning letters to Chinese pharmaceutical factory,look up the deficiency of our personnel qualification and training.Results and Conclusions On the basis of analyzing foreign GMP documents and the actual issue of person in Chinese pharmaceutical factory,establish a complete management system of GMP personnel qualification and training,guarantee the quality of drugs,take charge of the public＇s safe medications. |
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| Keywords: | GMP |
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