计算机标准操作规程管理系统在GLP实验室中的应用  

Application of computer SOP management system in GLP laboratory

作　　者：褚军友 

机构地区：[1]上海查士睿华生物医药科技有限公司,上海201203

出　　处：《中国新药杂志》2008年第12期1013-1014,共2页Chinese Journal of New Drugs

摘　　要：标准操作规程(SOP)的制订、管理和实施是GLP实验室建设的重要软件内容。SOP的新建、审批及版本更新等给其管理带来挑战,单纯的纸张化管理已不能适应GLP的快速发展。笔者就上述几方面建立一个较为规范的符合目前法规的SOP计算机化管理系统进行探讨。The preparation, management and implement of standard operating procedures （SOP） are im- portant soft content in the construction of GLP laboratories. However, GLP laboratories meet challenges of more new SOPs and their apportion and revision. Papers SOP management can not accommodate the rapid development of GLP. Here I set up a SOP management system which is compliance with current rules. Some characteristics in the system were discussed with peers for improving of SOP computer system.

关 键 词：GLP 标准操作规程 计算机化管理 

分 类 号：R95[医药卫生—药学]