| 任峰,梅蕾蕾,李存金,熊磊,胡媛,杜传龙,徐敏,廖辉军.药品检查过程中关于数据可靠性的研究与思考[J].中国药事,2021,35(3):243-249 |
| 药品检查过程中关于数据可靠性的研究与思考 |
| Research and Reflection on Data Integrity in the Process of Drug Inspection |
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| DOI：10.16153/j.1002-7777.2021.03.001 |
| 中文关键词: 数据可靠性 药品检查 典型案例 药品质量 |
| 英文关键词: data integrity drug inspection typical cases drug quality |
| 基金项目:任峰，博士，主要从事药品检查审评工作；Tel：(0791)88336027；E-mail：renf8801@126.com |
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| 中文摘要: |
| 目的：为提升医药行业整体水平，保障药品质量，保护和促进公众健康，结合药品监管过程中日常检查工作实践，探讨产生数据可靠性问题的原因和解决思路。方法：分析国内外关于药品数据可靠性指南和中美两国关于数据可靠性缺陷情况，以日常检查工作中的典型案例为抓手，重点阐述部分案例企业目前在数据可靠性方面存在的问题。结果与结论：自2016年FDA发布数据可靠性行业指南草案以来，数据可靠性问题越来越受到业内重视，但目前面临的形势依然严峻，需要从文化建设、体系建设、 人员培训等多方面提升数据可靠性。 |
| 英文摘要: |
| Objective: To improve the overall level of the pharmaceutical industry, to ensure the quality of drugs, and to protect and promote public health. Reasons and solutions for generating data integrity were discussed in combination with the daily inspection work in the process of drug supervision. Methods: Domestic and international guidelines on data integrity and its deficiency in China and the United States were analyzed. By taking the typical cases in the process of daily inspection as an instrumentality, this article focuses on elaborating the current problems in data integrity in some case companies. Results and Conclusion: Data integrity problems have received increasing attention from the industry since FDA issued the draft industry guidelines for data integrity in 2016, but the current situation we face is still severe. Data integrity needs to be improved from the aspects of cultural construction, system construction, personnel training and so on. |
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