摘要
随着药物安全性研究水平和GLP的规范化要求的提高,作为保证研究质量重要因素的GLP软件建设及其实施的进一步加强势在必行。本文对GLP实验室组织机构和人员、标准操作规程、研究工作实施过程及相关环节的管理、质量保证体系等GLP软件建设的基本内容、实施要求和发展趋势做一阐述。
With improvement of the drug safety evaluation level and the requirements for good laboratory practice （GLP） standardization, the software construction and its implementation are imperative to further strengthen, as the important guarantee of research quality in the GLP field. This paper reviews the basic content of GLP software construction in GLP laboratory and its implementation requirements and trends, which include organization and personnel, standard operating procedures, management of the research work and quality assurance system.
出处
《中国新药杂志》
CAS
CSCD
北大核心
2013年第9期1006-1009,共4页
Chinese Journal of New Drugs
基金
中央财政支持地方高校发展专项资金(闽教财2010246)
福建省政府专项资金(闽发改高技2009 648)
关键词
GLP
药物安全性评价
软件建设
good laboratory practice
drug safety evaluation
software construction
