药品检验机构的能力建设标准研究  

Ability standards for institution construction of drug inspecting

作　　者：高志峰[1] 林兰[1] 门瑛璇[1] 

机构地区：[1]中国食品药品检定研究院,北京100050

出　　处：《中国新药杂志》2016年第4期380-383,共4页Chinese Journal of New Drugs

摘　　要：2014年中国食品药品检定研究院化学药品检定所承担了"药品检验机构能力建设标准"研究任务,按照实施方案,研究团队采用文献调研、会议座谈、问卷调查和数据统计等一系列方法,在机构管理、业务能力、仪器设备与环境设施、专业技术人员、科研能力、信息化建设等多方面建立了标准;最后通过专家研讨与把关,形成了药品检验机构能力建设标准的研究报告,这为提升我国药品检验机构的能力水平,为新形势下设定药品检验体系的准入标准提供了参考。The task of researching the ability standards for construction of drug inspecting institutions was taken by the institute for chemical drug control of National Institute for Food and Drug Control in 2014. According the plan, the team used a series of methods such as literature survey, conference forum, questionnaires, data statistics, and so on. Then some ability standards were established, including institute managements, testing abilities, equipment and facilities, professionals, researches, information constructions and so on. Finally a report on the research was formed by means of experts discussing, which could improve the abilities of our institutions, at the same time, provide a reference for making access standards to the drug inspecting system in the new period.

关 键 词：药品 检验 能力 标准 

分 类 号：R95[医药卫生—药学]