| 我国血液制品企业GMP检查缺陷分析及监管思路探索 |
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| 引用本文： | 杨敬鹏,徐晓楠,王元.我国血液制品企业GMP检查缺陷分析及监管思路探索[J].中国药事,2019,33(6):605-608. |
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| 作者姓名： | 杨敬鹏 徐晓楠 王元 |
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| 作者单位： | 河南省食品药品审评查验中心, 郑州 450018,河南省口岸食品检验检测所, 郑州 450018,国家药品监督管理局食品药品审核查验中心, 北京 100044 |
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| 摘 要： | 目的：为完善我国药品GMP管理，提高企业GMP管理水平提供参考。方法：基于检查37家（次）血液制品生产企业在实施GMP中存在的381项缺陷，采用数据统计的方法进行分类评估，并提出针对性建议。结果与结论：目前，在我国血液制品GMP管理中，存在部分企业实施GMP主动意识不强、企业违反GMP成本较低等问题。建议通过落实企业主体责任、加大检查及处罚力度等办法，减少目前我国血液制品GMP监管中的问题。
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| 关 键 词： | 药品GMP 血液制品生产企业 缺陷 分析 对策 |
| 收稿时间： | 2019/3/27 0:00:00 |
Defect Analysis of GMP Inspection of Blood Product Enterprises and Suggestions on Supervision in China |
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| Yang Jingpeng,Xu Xiaonan and Wang Yuan.Defect Analysis of GMP Inspection of Blood Product Enterprises and Suggestions on Supervision in China[J].Chinese Pharmaceutical Affairs,2019,33(6):605-608. |
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| Authors: | Yang Jingpeng Xu Xiaonan and Wang Yuan |
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| Institution: | Henan Province Food And Drug Evaluation And Inspection Center, Zhengzhou 450018, China,Food Inspection and Testing Institute of Henan Province, Zhengzhou 450018, China and Center for Food and Drug Inspection of NMPA, Beijing 100044, China |
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| Abstract: | Objective:To provide references for improving pharmaceutical GMP supervision in China and GMP management level of enterprises. Methods:381 defects in the GMP inspection in 37 (times) blood product manufacturers were subject to classified evaluation by statistical methods. Countermeasures were put forward. Results and Conclusion:At present, in the GMP management of blood products in China, there are some problems such as weak initiative awareness of implementing GMP and low cost of violating GMP in some enterprises. It is suggested that the problems in GMP supervision of blood products in China be improued by implementing the main responsibility of enterprises, increasing inspection and punishment. |
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| Keywords: | pharmaceutical GMP blood product enterprise defect analysis countermeasure |
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