摘要
该研究对55家药品批发企业及零售连锁企业总部在GSP飞行检查过程中发现的缺陷项目进行统计,分析存在问题。结果显示企业执行GSP工作较好,但质量管理体系、机构和质量管理职责、人员与培训、设施与设备、校准与验证等环节存在问题依然较为集中,可以采用风险管理的思维加强质量管理工作。
The study counted the defect items found during the GSP flight inspection of the headquarters of 55 pharmaceutical wholesale companies and retail chain enterprises were counted, and the existing problems were analyzed. The results show that the enterprise performs the GSP work well, but the quality management system, institutions and quality management responsibilities, personnel and training, facilities and equipment, calibration and verification and other problems are still relatively concentrated. The risk management thinking can be used to strengthen the quality management work.
作者
王焕
吴生齐
张征
周军
WANG Huan;WU Sheng-qi;ZHANG Zheng;ZHOU Jun(Guangdong Provincial Drug Administration Evaluation and Certification Center,Drug Operation Evaluation and Certification Section,Guangzhou,Guangdong Province,510080 China)
出处
《中国卫生产业》
2020年第2期182-184,共3页
China Health Industry
关键词
药品经营质量管理规范
飞行检查
缺陷
风险管理
药品流通监管
Pharmaceutical business quality management specifications
Flight inspection
Defects
Risk management
Drug circulation supervision
