基于药品生产企业质量风险模型的常规检查计划制定方案研究  

Research on the Routine Inspection Planning Scheme Based on the Quality Risk Calculation Model of Pharmaceutical Manufacturers

作　　者：张婕颖 王雪雅 怀家好 李军[1] 茅宁莹[1] ZHANG Jie-ying;WANG Xue-ya;HUAI Jia-hao;LI Jun;MAO Ning-ying(China Pharmaceutical University)

机构地区：[1]中国药科大学

出　　处：《中国食品药品监管》2025年第3期110-127,共18页China Food & Drug Administration Magazine

摘　　要：目的:探究制定基于风险管理的药品生产企业常规检查工作方案,以实现集约检查资源、平衡药品监管能力与检查需求、优化监管资源配置。方法:基于德尔菲法和层次分析法,构建药品生产企业质量风险模型,设计基于药品生产企业质量风险模型的常规检查计划。结果与结论:本研究构建了包含3个一级指标、11个二级指标及17个三级指标的药品生产企业质量风险模型,并设计基于该模型的常规检查计划,经专家咨询验证具有科学合理性,能够实现对药品生产企业质量风险的量化评分与分级监管,为药品监管资源配置提供科学依据。Objective:This study aims to explore and formulate routine inspection plans for pharmaceutical manufacturers based on risk management,optimize inspection resource allocation,balance drug supervision capabilities with inspection needs,and optimize regulatory resource allocation.Methods:Based on the Delphi method and Analytic Hierarchy Process,a quality risk calculation model for pharmaceutical manufacturers was established,and a routine inspection plan was designed based on this model.Results&Conclusions:This study successfully developed a quality risk assessment model for pharmaceutical manufacturers,consisting of 3 primary indicators,11 secondary indicators,and 17 tertiary indicators,along with an associated routine inspection plan.Expert consultations confirmed that the model is scientifically sound and applicable.The model enables quantitative risk assessment and risk-based classification of pharmaceutical manufacturers,offering a scientific basis for optimizing regulatory resource allocation.

关 键 词：药品检查 风险管理 药品生产企业 质量风险 常规检查 

分 类 号：R95[医药卫生—药学]