GLP实验室计算机化系统质量保证关键点的探讨  

Quality assurance of computerized system for GLP laboratory

作　　者：李红[1] 吴纯启[1] 韩刚[1] 董延生[1] 郭巧珍[1] 王建京[1] 万淑芳[1] 马华智[1] 王全军[1] 

机构地区：[1]军事医学科学院毒物药物研究所抗毒药物与毒理学国家重点实验室(军事医学科学院)国家北京药物安全评价研究中心,北京100850

出　　处：《药物评价研究》2017年第4期433-436,491,共5页Drug Evaluation Research

基　　金：重大新药创制科技重大专项(2013ZX09302303;2012ZX09301-001-008);北京市科委基金项目(Z131100006513010)

摘　　要：结合欧美国家对药品非临床研究质量管理规范(GLP)实验室计算机化系统的规定,针对计算机化系统的特点,对计算机化系统管理质量保证(QA)的关键点进行了探讨与总结,包括计算机化系统的验证、使用过程中的控制、定期维护及安全防护、电子数据的保存等方面,以期为国内计算机化管理程度普遍不高的GLP实验室提供参考,提高药品评价水平。得到的体会包括:通过多次检查或审查,找出容易出问题的地方,定为风险点;制定有针对性的QA检查计划,对计算机化系统着重实施基于风险的检查,并针对发现的问题适时调整QA的检查计划,保证QA的检查或审查更具有针对性和有效性。In view of the characteristics of the computerized system,the key points in the quality assurance （QA） of the computerized system was discussed and summarized combined with the requirements of the GLP laboratory in Europe and America.The validation of computerized system,the control during the use of computerized system,period maintenance and safety protection of computerized system,archives of electronic data was discussed,expecting to provide reference for the management of computerized system in Chinese GLP laboratory which is generally not high currently.The experiences were obtained as follow：Through repeated inspection and review,the problem was found and set as the risk point;a targeted QA inspection plan was made focusing on the risk-based inspection and the QA inspection plan was timely adjusted according to the problems,which ensures the pertinence and validity of the QA inspection.

关 键 词：计算机化系统 GLP实验室 质量保证(QA) 药品评价 

分 类 号：R954.7[医药卫生—药学]