基于药效评价的质量管理规范设计、建设和应用  

Design,Construction and Application of Quality Management Practices Based on Efficacy Evaluation

作　　者：范长迎 危晨阳 邓晓霞 杨志强 FAN Chang-ying;WEI Chen-yang;DENG Xiao-xia;YANG Zhi-qiang(Kangtai Medical Testing Services Hebei Co.,Ltd.)

机构地区：[1]康泰医学检验服务河北有限公司

出　　处：《中国标准化》2025年第5期223-227,共5页China Standardization

基　　金：廊坊市科技局项目“廊坊市临床前药效评价技术研发中心”(项目编号:2023)资助。

摘　　要：国内药效评价技术研发结果质量参差不齐、可重现性低、可信度低,这个现象与国内药效评价技术研发过程没有建立实施统一、明确的质量管理规范有很大关系。本文基于“廊坊市临床药效评价技术研发中心”科研课题,创新性地提出建立药效评价研发技术质量管理规范,为药效评价研发中每个环节和结果的质量提供重要保障,其中包括400余种动物疾病模型的标准操作规程。通过质量体系文件的应用和质量管理体系的运行,进行内部监督、质量监控、同行比对、能力确认、内管审和外部政府监管等质量活动,实现质量管理体系的持续、有效运行,以此提升药效评价研发结果的准确度、可重现性和可信度,使药效评价研发过程更加科学、真实、可靠和可溯源。The quality of research and development results of domestic efficacy evaluation technology is uneven,with low reproducibility and credibility,which has a lot to do with the lack of unified and clear quality management standards for the R&D process of domestic drug efficacy evaluation technology.Based on the scientific research project of the“Langfang Clinical Efficacy Evaluation Technology R&D Center”,this paper innovatively proposes developing a quality management standard for pharmacodynamic evaluation R&D technology,which can guarantee the quality of each link and results in the R&D of pharmacodynamic evaluation,including the standard operating procedures of more than 400 animal disease models.Through the implementation of quality system documents and the operation of the quality management system,quality activities such as internal supervision,quality monitoring,peer comparison,capability confirmation,internal management audit and external government supervision can be carried out to achieve the continuous and effective operation of the quality management system,so as to improve the accuracy,reproducibility and credibility of the R&D results of pharmacodynamic evaluation,and make the R&D process of pharmacodynamic evaluation more scientific,authentic,reliable and traceable.

关 键 词：质量管理规范 质量管理体系 药效评价技术研发 药物非临床研究质量管理规范 动物疾病模型 标准操作规程 

分 类 号：R95[医药卫生—药学]