体外诊断试剂质量体系考核的探讨  

Discussion on the Examination of the Quality Management System for External Diagnosis Reagent

作　　者：郭准[1] 

机构地区：[1]国家食品药品监督管理局药品认证管理中心,北京100061

出　　处：《中国药事》2010年第3期259-261,共3页Chinese Pharmaceutical Affairs

摘　　要：目的推进我国体外诊断试剂质量体系考核深入实施。方法分析体外诊断试剂质量体系考核试行后的结果、收获和存在的问题。结果与结论只有在实践中不断探索,及时回顾和总结,才能使体外诊断试剂质量体系考核稳步推进。Objective To boost the deep implementation of examination of quality system for external diagnosis reagent in china.Methods To analyze the results,findings and existing problems after the trying-out of examination of quality system for external diagnosis reagent.Results and Conclusion Only continuous penetration in practice,timely review and summary,can the examination of quality system for external diagnosis reagent be boosted steadily.

关 键 词：体外诊断试剂 试剂监管 体系考核 

分 类 号：R981.9[医药卫生—药品]