摘要
目的分析药品生产企业在执行《药品生产质量管理规范》过程中存在的主要问题,为优化现场检查提供建议,为药品监督管理部门制定监管措施提供参考。方法统计分析2023—2024年江西省660家次药品生产企业开展现场监督检查时发现的缺陷项及存在的主要问题,并提出针对性的改进建议。结果高频缺陷项集中在文件管理、机构与人员、质量控制与质量保证、设备、生产管理、厂房设施、物料与产品七个方面。结论企业应从加强文件管理的规范性、强化企业责任与人员培训,规范生产管理流程等方面完善质量管理体系,有针对性地改进自身缺陷;管理部门应优化资源配置,提升科学监管能力,以确保药品生产的质量和安全。
Objective To analyze the main problems existing in the implementation of the“Good Manufacturing Practice”by pharmaceutical manufacturing enterprises,provide suggestions for optimizing on-site inspections,and offer references for the formulation of regulatory measures by drug regulatory authorities.Methods Statistically analyze the defect items and main problems found during on-site supervision and inspection of 660 pharmaceutical manufacturing enterprises in Jiangxi Province from 2023 to 2024,and put forward targeted improvement suggestions.Results High-frequency deficiencies were concentrated in seven areas:documentation management,organization and personnel,quality control and assurance,equipment,production management,facilities,and materials/products.Conclusion Pharmaceutical manufacturers should strengthen documentation standardization,enhance personnel training,and refine production processes to improve quality management systems.Regulatory authorities should optimize resource allocation and advance scientific supervision capabilities to ensure drug quality and safety.
作者
曾晓琦
钟国豪
王子千
喻文进
ZENG Xiaoqi;ZHONG Guohao;WANG Ziqian;YU Wenjin(Jiangxi Drug Inspection Center,Nanchang Jiangxi 330029,China)
出处
《药品评价》
2025年第9期1155-1160,共6页
Drug Evaluation
基金
江西省药品监督管理局科研项目(2023GL15、2024GL15)。
