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药品生产企业现场检查缺陷项目分析及对策建议

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目的 为药品生产企业执行《药品生产质量管理规范》,提高药品生产质量管理提供对策建议.方法 采用回顾性统计分析方法,对2020年~2022年甘肃省429家药品生产企业现场检查发现缺陷项目进行分析.结果 按照出现频次统计,缺陷项目主要分布在设备、质量控制与质量保证、文件管理、机构与人员、附录中药饮片、厂房与设施、物料与产品、生产管理.结论 企业应进一步落实主体责任,提高安全生产意识,有针对性做好生产管理工作,注重药品生产质量管理人才培养及强化实际培训效果,建立符合自身实际的文件体系,保证质量体系有效运行.
Analysis of Defects in On-site Inspection of Pharmaceutical Manufacturing Enterprises and Countermeasures
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.

Gansu provincePharmaceutical manufacturerOn-site inspectionDefective itemsCountermeasures and suggestions

章文霞、徐大丽、贺学锋、刘宇琴、刘蓉、黄洁、刘刚、马银霞

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甘肃省药品监督管理局审核查验中心,甘肃兰州 730000

甘肃省药物警戒中心,甘肃兰州 730000

甘肃省 药品生产企业 现场检查 缺陷项目 对策建议

甘肃省药品科研项目

2022GSMPA0048

2024

海峡药学
中国药学会福建分会

海峡药学

影响因子:0.643
ISSN:1006-3765
年,卷(期):2024.36(8)