药品质量飞行检查现状、问题及对策研究
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摘要
目的:为我国药品质量飞行检查的不断完善提出建议,以供借鉴和参考。方法:采用文献查阅法、观察法和比较研究法等方式深入研究药品质量飞行检查现状,找出其中存在的问题。结果与结论:我国药品质量飞行检查现状趋于常态化,药品监督管理部门越来越广泛地运用飞行检查对违法违规企业进行惩治,效果显著;药品质量飞行检查已经从概念化走向系统化,使药品质量飞行检查系统愈发完善、成熟,但仍存在保密性不足、监管能力有限、数据可靠性不高、法律法规不够完善等问题。药品质量飞行检查要充分利用社会和媒体力量提高检查力度,推行药品飞行检查方式,并与交叉检查和日常检查相结合,发挥药品质量飞行检查的作用。
Objective: To put forward suggestions and references for continuous improvement of drug quality flight inspection in China. Methods: The current status of drug quality flight inspection was analyzed in details by using the methods of literature reviews, observation and comparative study in order to find out the problems. Results and Conclusion: The current status of drug quality flight inspection in China tends to be normalized. Drug regulatory department has increasingly used flight inspection to punish illegal enterprises and the effects are remarkable. The drug quality flight inspection has changed from conceptualization to systemization, which makes the drug quality flight inspection system more perfect and mature, but there still remain some problems such as insufficient confidentiality, limited regulatory capacity, low reliability of data, imperfect laws and regulations and so on. Drug quality flight inspection should make full use of social and media forces to enhance the inspections, carry out the mode of drug flight inspection and combine the cross inspection with the daily inspection to fulfill the function of drug quality flight inspection.
Objective: To put forward suggestions and references for continuous improvement of drug quality flight inspection in China. Methods: The current status of drug quality flight inspection was analyzed in details by using the methods of literature reviews, observation and comparative study in order to find out the problems. Results and Conclusion: The current status of drug quality flight inspection in China tends to be normalized. Drug regulatory department has increasingly used flight inspection to punish illegal enterprises and the effects are remarkable. The drug quality flight inspection has changed from conceptualization to systemization, which makes the drug quality flight inspection system more perfect and mature, but there still remain some problems such as insufficient confidentiality, limited regulatory capacity, low reliability of data, imperfect laws and regulations and so on. Drug quality flight inspection should make full use of social and media forces to enhance the inspections, carry out the mode of drug flight inspection and combine the cross inspection with the daily inspection to fulfill the function of drug quality flight inspection.
引文
[1]国家食品药品监督管理总局.国家食品药品监督管理总局令第14号药品医疗器械飞行检查办法[S].2015.
[2]大众网.山东药品企业接受飞行检查,起底171家问题药企[EB/OL].(2015-12-28)[2018-06-01].http://jining.dzwww.com/sdnews/201512/t20151228_13577203.htm.
[3]张旭.企业聚焦[N].中国医药报,2016-07-13(A08).
[4]郝岚.“飞检”撕开了药品监管的两个时代[J].中国药店,2016,(10):6-6.
[5]中国质量新闻网.安徽省食药监局公布2016年药品GMP跟踪飞行检查工作方案[EB/OL].(2016-02-26)[2018-06-01].http://www.cqn.com.cn/ms/content/2016-02/26/content_2652220.htm.
[6]国家食品药品监督管理总局.国家食品药品监督管理总局令第13号药品经营质量管理规范[S].2016.
[7]刘清峰.医疗器械经营质量规范飞行检查及对企业的建议[J].中国物流与采购,2016,(24):68-79.
[8]安徽省食品药品监督管理局.皖食药监法秘[2017]358号关于印发安徽省药品飞行检查实施办法(试行)的通知[S].2017.
[9]甘红红.“飞行检查”--一种可供借鉴的手段[J].福建质量管理,1994,(6):13-13.
[10]刘龙茜,张丽青.药品生产企业GMP飞行检查的研究与分析[J].企业改革与管理,2016,(24):222-224.
[2]大众网.山东药品企业接受飞行检查,起底171家问题药企[EB/OL].(2015-12-28)[2018-06-01].http://jining.dzwww.com/sdnews/201512/t20151228_13577203.htm.
[3]张旭.企业聚焦[N].中国医药报,2016-07-13(A08).
[4]郝岚.“飞检”撕开了药品监管的两个时代[J].中国药店,2016,(10):6-6.
[5]中国质量新闻网.安徽省食药监局公布2016年药品GMP跟踪飞行检查工作方案[EB/OL].(2016-02-26)[2018-06-01].http://www.cqn.com.cn/ms/content/2016-02/26/content_2652220.htm.
[6]国家食品药品监督管理总局.国家食品药品监督管理总局令第13号药品经营质量管理规范[S].2016.
[7]刘清峰.医疗器械经营质量规范飞行检查及对企业的建议[J].中国物流与采购,2016,(24):68-79.
[8]安徽省食品药品监督管理局.皖食药监法秘[2017]358号关于印发安徽省药品飞行检查实施办法(试行)的通知[S].2017.
[9]甘红红.“飞行检查”--一种可供借鉴的手段[J].福建质量管理,1994,(6):13-13.
[10]刘龙茜,张丽青.药品生产企业GMP飞行检查的研究与分析[J].企业改革与管理,2016,(24):222-224.