中国药物警戒 ›› 2018, Vol. 15 ›› Issue (1): 20-23.

• 法规与管理研究 • 上一篇    下一篇

药品生产企业数据可靠性缺陷分析

颜若曦, 曹轶*   

  1. 国家食品药品监督管理总局食品药品审核查验中心,北京 100061;
  • 收稿日期:2018-02-12 修回日期:2018-02-12 出版日期:2018-01-20 发布日期:2018-02-12
  • 通讯作者: *曹轶,男,硕士,工程师,药品检查。E-mail：ssscaoyi@163.com
  • 作者简介:颜若曦,男,硕士,高级工程师,生物化工。

Analysis of Data Integrity Defects in Drug Manccfacturers

YAN Ruo-xi, CAO Yi*   

  1. Center for Food and Drug Inspection of CFDA, Beijing 100061 China;
  • Received:2018-02-12 Revised:2018-02-12 Online:2018-01-20 Published:2018-02-12

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摘要： 目的 研究药品生产企业数据可靠性问题,供监管部门及制药行业参考借鉴。方法 对国内外数据管理相关法规指南进行梳理,并对药品生产企业常见数据可靠性缺陷进行分类总结,根据类别对国家食品药品监督管理总局近2年飞行检查、2016年药品GMP跟踪检查及国外检查观察中发现的数据可靠性缺陷进行统计分析。结果 明确数据管理的基本要求,识别出我国药品生产企业存在的主要数据可靠性问题及产生原因。结论 针对药品生产企业数据可靠性问题提出改进思路与建议,促进制药行业数据管理能力的提升。

关键词: 数据可靠性, 药品生产, 计算机化系统

Abstract: Objective To study data integrity defects of drug manufacturers, in order to provide reference for regulators and pharmaceutical industry. Methods By analyzing the domestic and foreign data management laws and guides, and classifying the common data integrity defects in drug manufacturers, the study makes statistical analysis on the data integrity defects which were found in CFDA GMP unannounced inspection, GMP follow-up inspection and observation of international inspection in 2016. Results The basic requirements of data management are defined. Main data integrity defects which existing in drug manufacturers and causes are identified. Conclusion The paper provides suggestions on improving data management and references to enhance the data management ability in the pharmaceutical industry.

Key words: data integrity, drug production, computerized system

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