基于现场检查探究药物非临床安全性评价研究机构质量管理的风险因素和提升策略

Exploring risk factors and improvement strategies for quality management in non-clinical drug safety evaluation institutions based on on-site inspections

摘要

目的: 通过对药物非临床安全性评价研究机构运行管理中关键因素的识别和分布研究,以期为其质量管理体系运行中的风险识别及质量提升提供一种可行的方法。方法: 选取各类型现场检查的部分发现问题,包括首次认证检查、延续认证检查、新增试验项目检查为研究对象,以关键要素识别进行分类,通过帕累托法则识别药物非临床安全性评价机构质量管理的主要风险因素,构建一种基于外部检查发现问题的风险识别模型,用于质量管理的提升。结论: 通过关键要素提取,以外部检查发现问题为数据基础,以模型为工具,可以对质量管理风险因素进行半定量分析,能够为质量管理的数字化转型提供路径示范,协助风险管理。

Abstract

Objective: To develop a practical methodology for risk identification and quality improvement in the quality management system of non-clinical drug safety research institutions,i.e.,Good Laboratory Practice （GLP）institutions,by identifying and analyzing the distribution of key factors in the operation and management of GLP institutions. Methods: Certain inspection fundings from different inspection types,including initial certification inspections,renewal certification inspections,and inspections for newly added test items,were used as analyzing items.Based on the demo data,key factors are identified and categorized,and the Pareto principle was applied to determine the main risk factors in the quality management of GLP institutions.Based on this,a risk identification model was constructed using externally identified inspection findings to enhance the level of quality management. Conclusion: By identifying and categorizing key factors,and utilizing findings from external inspections as the data foundation,this model serves as a tool for semi-quantitative analysis of quality management risk factors.It provides a reference framework for the digital transformation of quality management and facilitates risk management.

关键词

药物非临床安全性评价研究机构 / 数字化质量管理 / 风险管理 / 模型路径

Key words

non-clinical drug safety evaluation institution / digital quality management / risk management / model pathway

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