质量风险管理在注射剂和滴眼剂质量控制中的应用  

Application of Quality Risk Management in Quality Control of Injections and Eye Drops

作　　者：田霖[1] 赵燕君 仪忠勋 谢兰桂[1] 肖新月[1] 杨会英[1] Tian Lin;Zhao Yanjun;Yi Zhongxun;Xie Langui;Xiao Xinyue;Yang Huiying(NMPA Key Laboratory for Quality Research and Evaluation of Pharmaceutical Excipients,National Institutes for Food and Drug Control,Beijing 100050,China)

机构地区：[1]国家药品监督管理局药用辅料质量研究与评价重点实验室,中国食品药品检定研究院,北京100050

出　　处：《中国药事》2023年第11期1271-1281,共11页Chinese Pharmaceutical Affairs

摘　　要：目的:查找注射剂和滴眼剂生产的关键控制点,制定预防措施,为注射剂和滴眼剂提供良好的质控保障。方法:调研两家医药企业,采用危害分析和关键控制点法、失败模式影响分析等风险管理工具,查找生产过程的风险点,开展风险评估和风险控制,制定预防措施。结果:对风险系数处于高风险和中等风险水平的风险源采取控制措施后,各风险点的风险等级有所降低。结论:注射剂和滴眼剂原辅包须与制剂的生产环境相匹配,生产监测的全面化与规范化有待提升。Objective:To provide good quality control for injections and eye drops by identifying critical control points for the production of injections and eye drops and developing preventive measures.Methods:Two pharmaceutical enterprises were investigated.Risk management tools such as hazard analysis and critical control point method and failure mode effects analysis were used to find out the risk points in the production process.Risk assessment and risk control were carried out,and preventive measures were put forward.Results:Subsequent to taking control measures for risk sources with high risk coefficient and medium risk level,the risk grade of each risk point was reduced.Conclusion:The active pharmaceutical ingredients,pharmaceutical excipients and packing materials of injections and eye drops should match the production environment of the preparation,and the comprehensive and standardization of production monitoring needs to be improved.

关 键 词：注射剂 滴眼剂 质量风险管理 原辅包 风险评估 

分 类 号：R95[医药卫生—药学]