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安徽省保健食品生产许可现场检查情况分析
引用本文:吴文华,王丽娜,王贺,杨金堂.安徽省保健食品生产许可现场检查情况分析[J].安徽农业科学,2017,45(23).
作者姓名:吴文华  王丽娜  王贺  杨金堂
作者单位:安徽省食品药品审评认证中心,安徽合肥,230051;合肥市食品药品监督管理局,安徽合肥,230031
摘    要:研究安徽省近年来保健食品生产许可现场检查情况,为检查员开展许可检查、食品药品监管部门进行日常监管及保健食品生产企业加强质量管理提供参考。以2014—2016年75份安徽省保健食品许可检查结果为研究对象,采用计量学方法对其进行分类统计分析。结果表明:生产过程缺陷项目共有291次,设计与设施缺陷项目共有199次,品质管理缺陷项目共有157次,原料缺陷项目共有148次,人员管理、卫生管理、储存与运输缺陷项目共有120次。保健食品产品总体上技术水平不高,生产企业质量管理水平不高,许可检查总体通过率较低,但呈现逐年上升趋势。建议企业加强生产质量管理,监管部门加强监管,检查员提升现场检查水平。

关 键 词:保健食品生产企业  生产许可  现场检查  缺陷项目

Field Inspection of Health Food Production License in Anhui Province
Abstract:To study the on-site inspection of health food production license in Anhui Province in recent years,so as to provide reference for the inspector to carry out licensing inspection,supervise the food and drug administration and supervise the quality management of health food producing enterprises.The results of 75 licensed food hygiene tests in Anhui during 2014-2016 were analyzed by statistical methods.A total of 291 production process defects in the project,a total of 199 times the design and facilities of defective items,a total of 157 quality management defects of the project,a total of 148 raw materials defects project,personnel management,health management,storage and transport of defective items is 120.The quality of health food products is not high,and the quality management level of the production enterprises is not high.The overall pass rate of the licensed examination is low,but it shows an upward trend year by year.It is suggested that enterprises should strengthen the level of production quality management,strengthen supervision by the regulatory authorities,and increase the on-site inspection level of inspectors.
Keywords:Health food manufacturing enterprises  Production license  Site inspection  Defective item
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