| 河南省医用氧生产企业实施新版药品GMP缺陷分析 |
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| 引用本文： | 张伟奇,谢芝丽,党明安,李海剑.河南省医用氧生产企业实施新版药品GMP缺陷分析[J].中国药事,2017,31(5):515-519. |
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| 作者姓名： | 张伟奇 谢芝丽 党明安 李海剑 |
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| 作者单位： | 河南省食品药品审评查验中心, 郑州 450000,河南省食品药品审评查验中心, 郑州 450000,河南省食品药品审评查验中心, 郑州 450000,河南省食品药品审评查验中心, 郑州 450000 |
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| 摘 要： | 目的：研究分析河南省医用氧生产企业实施新版药品GMP存在的主要问题，为有效实施新版药品GMP提供建议。方法：对本省34家医用氧生产企业的45次GMP认证跟踪现场检查发现的缺陷进行统计和分析。结果与结论：本省医用氧生产企业在质量管理与质量控制、文件管理、设备管理、机构与人员、确认与验证、生产管理等方面还存在不足，企业应当持续不断的改进质量管理体系，从而确保产品质量。
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| 关 键 词： | 医用氧 药品生产质量管理规范 缺陷项目 现场检查 |
| 收稿时间： | 2017/2/8 0:00:00 |
On Defects in the Implementation of New Edition GMP for Drugs in Medical Oxygen Production Enterprises in Henan Province |
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| Zhang Weiqi,Xie Zhili,Dang Ming''an and Li Haijian.On Defects in the Implementation of New Edition GMP for Drugs in Medical Oxygen Production Enterprises in Henan Province[J].Chinese Pharmaceutical Affairs,2017,31(5):515-519. |
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| Authors: | Zhang Weiqi Xie Zhili Dang Ming'an and Li Haijian |
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| Institution: | Henan Provincial Food and Drug Evaluation and Inspection Center, Zhengzhou 450000, China,Henan Provincial Food and Drug Evaluation and Inspection Center, Zhengzhou 450000, China,Henan Provincial Food and Drug Evaluation and Inspection Center, Zhengzhou 450000, China and Henan Provincial Food and Drug Evaluation and Inspection Center, Zhengzhou 450000, China |
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| Abstract: | Objective: To find out the main problems in the implementation of new edition GMP for drugs in medical oxygen production enterprises in Henan Province and put forward suggestions to implement the new edition GMP for drugs effectively. Methods: All defective items found in 34 medical oxygen production enterprises in the 45 tracking and on-site inspections for GMP certification were statistically analyzed. Results and Conclusion: Some deficiencies still existed in the following aspects, such as quality assurance and quality control, documentation management, equipment management, organization and personnel, qualification and validation, production management and so on. The medical oxygen production enterprises should continuously improve the quality management system so as to ensure products quality. |
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| Keywords: | medical oxygen quality management standard for drug manufacture defective items on-site inspection |
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