FDA警告信中数据完整性主要问题浅析及启示

Analysis and enlightenment of the main problems of data integrality in FDA warning letters

通过对发达国家或组织发布的数据规范管理指南的研究,分析FDA发布的境外检查警告信中关于生产质量方面存在的主要数据可靠性问题,为我国药品生产企业完善数据管理提供参考。数据可靠性问题主要表现在:隐瞒、丢弃、修改甚至编造数据。我国药品生产企业需重视诚信体系建设,规范习惯性行为,提升数据规范管理能力,适应行业发展需要。

Studying data management guidelines issued by developed countries and organizations,and analyzing data integrity in the warning letters issued by US FDA,and to provide references for improving data management in drug manufacturing enterprises.Mainly data integrity deficiencies displays in concealed,discarded,amend or even fabricated data.Drug manufacturing enterprises should pay more attention to credit system construction,standardize the habitual behavior and improve the data management ability in order to suit the needs of industrial development.