管若青, 段亚波, 王楠, 代港. 获批消毒产品2012年现场抽检情况分析[J]. 环境卫生学杂志, 2014, 4(3): 280-282.
    引用本文: 管若青, 段亚波, 王楠, 代港. 获批消毒产品2012年现场抽检情况分析[J]. 环境卫生学杂志, 2014, 4(3): 280-282.
    Guan Ruoqing, Duan Yabo, Wang Nan, Dai Gang. Analysis on Status of Disinfection Products Checked on Spot in 2012[J]. Journal of Environmental Hygiene, 2014, 4(3): 280-282.
    Citation: Guan Ruoqing, Duan Yabo, Wang Nan, Dai Gang. Analysis on Status of Disinfection Products Checked on Spot in 2012[J]. Journal of Environmental Hygiene, 2014, 4(3): 280-282.

    获批消毒产品2012年现场抽检情况分析

    Analysis on Status of Disinfection Products Checked on Spot in 2012

    • 摘要:
      目的 分析获得原卫生部批准消毒产品的抽检情况, 发现问题, 提出建议, 供取消消毒产品审批后加强产品市场监管参考。
      方法 对2012年卫生部卫生监督中心组织抽检的45家消毒产品生产企业的67个消毒产品的现场检查数据进行分析。
      结果 有97%的企业是在取得企业卫生许可证后进行消毒产品生产, 但也有10%以上的企业超范围生产经营或者任意变更生产场所; 88%的企业生产条件完全符合要求、实际生产工艺与申报一致; 76%的产品原料投加与申报配方一致; 78%的原料能提供购货凭证; 95%的产品能够提供市售产品标签说明书, 但实际查验的标注内容完全符合《消毒产品标签说明书管理规范》仅占82%;也有部分产品标签或说明书标注的产品名称、有效成分含量、使用范围、使用方法、有效期与产品批件不一致。
      结论 消毒产品生产企业管理和软硬件建设比较规范, 但在产品生产和市场管理中尚存在亟待解决的问题, 需要在日常监管中加大企业和产品监管力度。

       

      Abstract:
      Objectives To provide reference for the supervision of disinfection products in markets after the approval for the production of previous disinfection items being cancelled, and to seek problems and develop proposals.
      Methods Analyzing the data examined on the spot of 67 disinfection products from 45 domestic enterprises in 12 provinces, the product items being sampled and checked by MOH in 2012.
      Results The production of disinfection products was started after the hygienic license being obtained in 97% of enterprises, while the production was beyond the scope or the production places were changed in more than 10% of enterprises. The production condition in 88.46% of enterprise has met the requirement and the practical production process were in accordance with the declaration in license. The raw materials added to products in 76% of enterprises were in accordance with the declared formula in license. The purchase certificate could be provided for 78% of the raw materials. Labels and instruction manuals of products could be provided by 95% of enterprises, but only 82% of the marked contents agreed with the requirement in the Regulations for the Label and Instruction of Disinfection Products. The product name, valid content, usage scope, the method of use and the valid duration in some products were not in accordance with the declaration in license.
      Conclusions The management of disinfection products enterprises was good, while there were urgent problems to be solved about product manufacturing and market management. It is necessary to strengthen the supervision on enterprises and products.

       

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