检验检测机构化学试剂QC实验室的关键要素分析  

On the Key Points of Chemical Reagent QC Laboratory in Testing and Inspection Institutions

作　　者：马丽颖[1] 张陈祎 郭亚新[1] 邹健[1] 

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》2017年第8期904-909,共6页Chinese Pharmaceutical Affairs

摘　　要：目的:验证实验试剂的质量,为检验工作选择符合要求的化学试剂提供数据依据。方法:对QC实验室成立以来已完成的2批常用化学试剂的检测情况进行总结,并对样品、人员、仪器设备、实验材料、方法标准、环境等6个控制要素进行分析。结果与结论:检验检测机构所使用的实验材料品质,是影响其工作结果的重要因素,建立质量控制实验室(QC实验室)并进行化学试剂质量控制具有重要意义,便于筛选合格供应商,指导并规范实验用试剂及耗材的采购,从而进一步满足食品药品各项检验检测工作的需要,确保检验检测数据与结论的公正性、有效性。Objective： To verify the quality of chemical reagents, and provide the data for testing work to choose requested chemical reagents. Methods： The completed detection processes of 2 batches of the commonly used reagents were summarized, and then six control elements, the sample, the personnel, the instrument, the experimental material, the method standard, and the experimental environment, were analyzed. Results and conclusion： The quality level of chemical reagent is an important factor influencing the outcomes of work in testing and inspection institutions. It is of great significance to set up a quality control laboratory （QC lab） and conduct quality control of chemical reagents, which facilitates the screening of qualified suppliers, provides guidance and specification for the purchase of experimental reagents and consumables, fulfills the food and drug inspection and detection tasks, and ensures the impartiality and validity of the detection data and results.

关 键 词：化学试剂 质量控制实验室 样品 人员 仪器设备 实验材料 方法 环境 

分 类 号：H083[语言文字—语言学] R95[医药卫生—药学]