| 药品GMP认证现场检查质量风险分析与控制 |
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| 引用本文： | 江映珠,邹毅.药品GMP认证现场检查质量风险分析与控制[J].广东药学院学报,2010,26(3):302-304. |
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| 作者姓名： | 江映珠 邹毅 |
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| 作者单位： | 广东省食品药品监督管理局,审评认证中心,广东广州510080 |
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| 摘 要： | 目的探讨药品GMP认证现场检查质量风险控制。方法以质量风险管理原则为基础,识别和评价现场检查风险,提出控制现场检查风险的有效方法,以消除或降低现场检查质量风险,提高药品GMP认证检查质量。结果与结论随着药品GMP认证检查的深入开展,应该深刻地认识现场检查的质量风险,并运用风险管理科学方法有效控制现场检查质量风险,以确保药品GMP认证工作质量。
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| 关 键 词： | 药品GMP认证 风险管理 现场检查 |
The risk analysis and controls of GMP onsite inspection |
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| JIANG Ying-zhu,ZOU Yi.The risk analysis and controls of GMP onsite inspection[J].Academic Journal of Guangdong College of Pharmacy,2010,26(3):302-304. |
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| Authors: | JIANG Ying-zhu ZOU Yi |
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| Institution: | (Guangdong Food and Drug Administration Center for Evaluation ＆ Certification,Guangzhou,Guangdong 510080,China) |
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| Abstract: | Objective To study the risk control of on site inspection of GMP compliance certification.Methods According to the principle of quality risk management,risks of on site inspection of GMP compliance certification are identified and evaluated.Effective measures to control risks of on site inspection are advised to eliminate and reduce quality risks of on site inspection,and improve quality of on site inspection of GMP compliance certification.Results and Conclusion Along with further development of GMP compliance certification,we must know well enough quality risks of on site inspection of GMP compliance certification.Measures of risk management science must be adopted to control quality risks of on-site inspection of GMP compliance certification and improve quality of GMP compliance certification. |
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| Keywords: | GMP compliance certification risk management on site inspection |
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