基于药品年度报告变更与偏差的生产风险管理评价模型构建

Construction of Production Risk Management Evaluation Model Based on Changes and Deviations in Annual Drug Reports

目的为药品监管部门依生产风险开展监管活动提供依据。方法基于相关法律法规、文献及生产企业药品年度报告中有关变更和偏差的说明,采用德尔菲法对药品生产企业风险管理的指标进行筛选并确立指标体系;采用层次分析法,以Python 3.9软件包计算各指标权重;利用模糊综合评价法建立模糊判断矩阵,构建模糊评价模型,并验证。结果建立变更与偏差生产风险三级指标体系,其中一级指标2个(变更和偏差),二级指标15个,三级指标64个。随机抽取10家企业的药品年度报告,以风险管理水平阈值为标准,模拟的10个数据中有8个满足,准确率达80.00%。结论所建立的模型能有效评估药品生产企业质量管理的风险水平,可为药品监管部门进行有针对性的检查提供可量化的参考依据。

Objective To provide a basis for drug regulatory departments to carry out regulatory activities based on production risks.Methods Based on relevant laws,regulations,literature,descriptions of change and deviation in the annual drug reports of manufacturing enterprises,the Delphi method was used to screen the indicators of risk management in drug manufacturing enterprises and establish an indicator system.The analytic hierarchy process was used to calculate the weights of each indicator by the Python 3.9 software package.The fuzzy comprehensive evaluation method was used to establish a fuzzy judgment matrix and a fuzzy evaluation model,and the verification test was conducted.Results A production risk three-level indicator system based on changes and deviations was established,including two primary indicators(changes and deviations),15 secondary indicators,and 64 tertiary indicators.The annual drug reports of 10 enterprises were randomly selected,and eight out of the ten simulated data met the threshold of risk management level(standard),with an accuracy rate of 80.00%.Conclusion The established model can effectively evaluate the risk level of quality management in drug manufacturing enterprises,and provide quantifiable reference for targeted inspections by drug regulatory departments.