药物安全性评价GLP规范与SOP的关系及完善质量体系初探

Discussion on relationship between non-clinical safety evaluation GLP principles and SOP,and improvement of quality system

在药物非临床安全性评价良好实验室规范(GLP)体系下依据规范产生的标准操作规程(SOP),构成了GLP机构运行的基本体系架构,且在药物非临床安全性评价机构的持续性组织运行和试验实施过程中不断吸收获得的新经验、认知,并借鉴其他机构、行业、不同体系中的良好实践做法,融入到现有体系内,促进和引领质量管理体系持续改进,以满足日益严格的监管机构及委托方的合规性要求。依据国内外GLP相关的指导原则,分析GLP规范与SOP的关系,并提出完善SOP质量管理体系的途径,以期为药物非临床安全性机构优化、提升质量管理体系提供参考。

Under the Good Laboratory Practice(GLP)system,the Standard Operating Procedure(SOP)generated according to the GLP principles constitute the basic system framework for the operation of GLP test facilities,and will continue to absorb new experience and cognition during the test facilities'continuous organizational operation and study conduct process,and learn good practices from other test facilities,different quality systems,different industries,and integrate into the existing system,to promote and lead the continuous improvement of the quality management system of GLP test facilities to meet the compliance requirements of increasingly standardized and strict monitoring authorities and sponsors.Based on GLP at home and abroad and related guidelines,literature,etc.,this paper analyzes the relationship between GLP principals and SOPs,and proposes various ways to improve the existing quality management system of GLP test facilities,to provide effective references for each test facility to optimize and improve its quality management system.