OBJECTIVE To provide countermeasures and suggestions for drug production enterprises to imple-ment the Good Manufacturing Practice for Drugs and improve drug production quality management.METHODS Retrospective statistical analysis was used to analyze defects found during on-site inspections of 429 pharmaceutical production enterprises in Gansu Province from 2020 to 2022.RESULTS According to the frequency of occurrence statistics,defect projects were mainly distributed in equipment,quality control and assurance,document management,organization and personnel,appendix Chinese herbal medicine slices,factory buildings and facilities,materials and products,and production management.CONCLUSION Enterprises should further implement their main responsibil-ities,improve their awareness of safety production,carry out targeted production management work,pay attention to the cultivation of pharmaceutical production quality management talents and strengthen the actual training effect,establish a document system that is in line with their own reality,and ensure the effective operation of the quality system.
关键词
甘肃省/药品生产企业/现场检查/缺陷项目/对策建议
Key words
Gansu province/Pharmaceutical manufacturer/On-site inspection/Defective items/Countermeasures and suggestions
维普
万方数据