放射性药品生产企业GMP检查要点及缺陷分析

Analysis of key points and defects of GMP inspection in the radiopharmaceutical enterprises

通过总结放射性药品生产企业GMP现场检查的特异性关注点,并探讨分析2016-2019年江苏省放射性药品生产企业GMP现场检查缺陷情况,发现质量控制与质量保证、文件管理、设备方面的缺陷占据前3位。本文为药品检查员现场检查及企业持续提高GMP水平提供参考。

By summarizing the specific concern points of and analyzing the deficiencies of GMP inspections of radiopharmaceutical manufacturers in Jiangsu province from 2016 to 2019,the defects in quality control and quality assurance,document management,and equipment were found to occupy the top three.This article provides a reference for on-site inspection of drug inspectors and the continuous improvement of the GMP level of enterprises.