安徽省高风险药品生产企业依职责GMP符合性检查风险分析与对策  

Risk analysis and countermeasures on responsibility-based GMP compliance inspection of high-risk drug manufacturing enterprises in Anhui Province

作　　者：芮雪 叶六平 胡士高 RUI Xue;YE Liuping;HU Shigao(Anhui Center for Drug Evaluation and Inspection,Hefei 230051,China)

机构地区：[1]安徽省药品审评查验中心,安徽合肥230051

出　　处：《药学研究》2024年第10期1029-1034,共6页Journal of Pharmaceutical Research

基　　金：盖茨基金项目资助(粉液双室袋产品检查指南课题研究)。

摘　　要：为推动高风险药品生产企业持续符合药品生产质量管理规范(GMP),对近3年安徽省开展的高风险药品生产企业依职责GMP符合性检查的缺陷项目进行统计分析。共汇总缺陷项目1408项,包括严重缺陷7项、主要缺陷88项、一般缺陷1313项,主要分布于质量控制与质量保证、文件管理、无菌药品附录等方面。高风险药品生产企业应从落实主体责任、强化污染控制策略、建立长效培训机制、严格供应商管理、完善确认与验证、加强产品质量回顾分析等方面着手持续保障药品质量安全。In order to ensure continued adherence of high-risk drug manufacturing enterprises to GMP,a statistical analysis was performed on the deficiencies identified during the responsibility-based GMP compliance inspections conducted in Anhui Province from 2021 to 2023.A total of 1408 inspection defects were summarized,including 7 serious defects,88 major defects and 1313 general defects,which were mainly in the aspects of quality control and quality assurance,document management,sterile drug appendices,etc.High-risk drugs manufacturing enterprises should implement the main responsibility,strengthen contamination control strategy,establish long-term training mechanism,strictly manage suppliers,improve confirmation and verification and enhance product quality review analysis to continuously improve high-risk drugs quality and safety.

关 键 词：高风险药品 GMP检查 风险分析 

分 类 号：R95[医药卫生—药学]