质量控制实验室在供应品质量管理中的重要性  

Importance of Quality Management Supplies in Quality Control Laboratory

作　　者：马丽颖[1] 郭亚新[1] 张陈祎 郭凤[1] 邹健[1] Ma Liying Guo Yaxin Zhang Chenyi Guo Feng Zou jian＊(National Institutes for Food and Drug Control, Beijing 100050, China)

机构地区：[1]中国食品药品检定研究院,北京100050

出　　处：《中国药事》2016年第12期1298-1300,共3页Chinese Pharmaceutical Affairs

摘　　要：目的:建立药检系统供应品质量控制实验室,确保影响检测质量的消耗品符合实验室要求并可以进行质量溯源。方法:比较资质认定评审准则(CMA)、ISO/IEC17025:2005版的《检测和校准实验室能力的通用要求》、CNAS-CL01:2006版的《检测和校准实验室能力认可准则》及WHO的《药品质量控制实验室良好操作规范》(GPCL)等技术文件对供应品的要求,结合药检系统检测质量控制实验室的实际,探讨供应品的质量控制规范。结果:质量控制实验室在供应品验收过程中具有举足轻重的作用,尤其对供应品存在争议时,质量控制实验室可以通过检验数据验证结果,在验收工作中发挥重要作用。结论:采取集中采购的机构可建立质量控制实验室,对于检验任务的顺利完成是不可或缺的质量保障。Objective： To establish the quality control laboratory for drug control system supplies in order to ensure that the inspection quality can meet requirements of laboratory consumables and enable quality traceability. Methods： By comparing the accreditation criteria（CMA）, ISO/IEC17025： 2005 ＂ General requirements for testing and calibration laboratory capabilities ＂, CNAS-CL01：2006 ＂Accreditation criteria for the competence of testing and calibration laboratories ＂ and WHO ＂Good practices for pharmaceutical quality control laboratories ＂（GPCL） and other technical documents for supplies, combined with the actual laboratory quality control of drug control system detection, the quality control standardization of supplies was discussed. Results： The quality control laboratory plays an important role in the inspection of the supplies, especially for the controversial supplies, laboratory quality control verifies the results through inspection data, and plays an important role in the inspection work. Conclusion： The centralized procurement institutions can establish the quality control laboratory, which is an indispensable quality guarantee for the successful completion of the inspection and testing tasks.

关 键 词：质量控制 技术规范 服务和供应品 实验室管理 

分 类 号：H083[语言文字—语言学] R95[医药卫生—药学]