基于ADR报告数据的MAH生产线风险预警系统的研发与应用

Development and Application of MAH Production Line Risk Warning System Based on ADR Report Data

目的:为药品上市许可持有人(MAH)有效利用药品不良反应(ADR)报告数据,对生产质量风险进行主动监测与控制、开展药品生产风险管理提供技术方法。方法:通过建立三维风险矩阵、风险趋势模型,设计研发了基于ADR报告数据的MAH生产线风险预警系统,并根据某企业的ADR报告数据对系统的主要功能进行实例应用分析。结果:初步建立了MAH生产线风险预警系统,其主要框架包括数据来源与处理、模型构建(三维矩阵模型包括可能性指标、严重程度指标和敏感性指标等3个维度,风险趋势模型则根据产品生产批号编制原则设置)、结果输出与分析等三大模块,主要包含系统配置、生产线信号检测、可视化统计预警、ADR报告管理、标准数据管理等五大功能模块。通过某企业ADR报告数据的应用分析显示,该系统可实现对其生产线风险及时、主动地检测及预警,能较直观地反映其高风险生产线、品种及批号,与该企业品种的实际安全性情况相吻合。结论:该系统可帮助MAH利用ADR报告数据及时、主动地监测药品生产质量风险,排查高风险生产线、高风险品种、高风险批号的风险因素,辅助决策风险排查方向。

OBJECTIVE:To provide technical methods for marketing authorization holder(MAH)to effectively use the data of adverse drug reaction(ADR),actively monitor and control the production quality risk,and carry out drug production risk management.METHODS:Through establishing three-dimensional risk matrix and risk trend model,the risk early warning system of MAH production line based on ADR report data is designed and developed;the main functions of the system were applied and analyzed according to the actual ADR report data of a certain company.RESULTS:MAH production line risk warning system was established preliminarily.The main framework included data source and and processing module,model construction module(three-dimensional matrix model included possibility index,severity index and sensitivity index,risk trend model was set according to the principle of product production batch number preparation),and result output&analysis module.Five major functional modules included system configuratio,production line signal detection,visual statistical early warning,ADR report management and standard data management.The application and analysis of ADR report data of a certain company showed that the system could realize detection and warning of the company’s production line risk,which intuitively reflected its high-risk production lines,varieties and batch numbers.It was consistent with the actual safety situation of the company’s varieties.CONCLUSIONS:The system can help MAH make use of ADR report data to actively monitor drug production quality risks in a timely manner,investigate risk factors for high-risk production lines,high-risk varieties and high-risk batch numbers,and assist in decision-making on the direction of risk investigation.