| 基于质量风险管理的药品原辅料供应商现场审计 |
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| 引用本文： | 赵鸿剑,梁毅. 基于质量风险管理的药品原辅料供应商现场审计[J]. 机电信息, 2012, 0(20): 20-23 |
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| 作者姓名： | 赵鸿剑 梁毅 |
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| 作者单位： | 中国药科大学国际医药商学院,江苏南京,210009 |
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| 摘 要： | 站在质量风险管理的角度上,探讨如何识别和评价现场审计的质量风险,运用风险管理科学方法有效控制这些风险,将会提高现场审计的质量,为药品生产安全有效、质量稳定提供有力保障。
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| 关 键 词： | 质量风险管理 药品 现场审计 |
The on-site audit for pharmaceutical raw materials supplier based on the quality risk management |
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| Zhao Hongjian Liang Yi. The on-site audit for pharmaceutical raw materials supplier based on the quality risk management[J]. Mechanical and Electrical Information, 2012, 0(20): 20-23 |
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| Authors: | Zhao Hongjian Liang Yi |
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| Affiliation: | Zhao Hongjian Liang Yi (International Business School,China Pharmaceutical University,Nanjing 210009,China) |
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| Abstract: | The article discusses about distinguishing and estimating the risk of quality based on the quality risk management. If the auditors can use the methods of risk management to control these risks, it will be beneficial to the on-site audit. |
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| Keywords: | quality risk management medicine on-site audit |
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