药用玻璃输液瓶线热膨胀系数测定能力验证  

Proficiency Testing of Determination of Coefficient of Linear Thermal Expansion for Medicinal Glass Infusion Bottles

作　　者：王颖[1] 齐艳菲 赵霞[1] 肖新月[1] WANG Ying;QI Yanfei;ZHAO Xia;XIAO Xinyue(National Institutes for Food and Drug Control,Beijing,China 100050)

机构地区：[1]中国食品药品检定研究院,北京100050

出　　处：《中国药业》2023年第5期80-83,共4页China Pharmaceuticals

摘　　要：目的组织实施药用玻璃输液瓶平均线热膨胀系数能力验证项目,评价检验机构对线热膨胀系数项目检验检测的业务能力。方法按《能力验证样品均匀性和稳定性评价指南》CNAS-GL003:2018标准规定的方法进行均匀性检验。以z比分数作为统计量,对参加实验室提供的检测结果进行评价,以稳健统计方法为选定算法,选择指定值为全部参加实验室提供测定结果的中位值、能力评定标准差为中位绝对离差。结果药用玻璃输液瓶样品的均匀性符合要求,可满足能力验证项目要求。28家实验室中,27家的检测结果判定为满意,满意率为96.43%;1家为可疑,可疑率为3.57%。结论多数实验室检测结果为满意,个别实验室的检验检测能力有待提高。药品监管部门需持续关注实验室能力建设,加强实验人员的业务培训。Objective To carry out a proficiency testing program for the determination of mean coefficient of linear thermal expansion for medicinal glass infusion bottles,and to evaluate the ability of the inspection institutions in testing the coefficient of linear thermal expansion.MethodsThe homogeneity testing was carried out in accordance with the method specified in the Guidance on Evaluating the Homogeneity and Stability of Samples Used for Proficiency Testing(CNAS-GL003:2018).The z-score was used as statistic to evaluate the testing results provided by the participating laboratories.The robust statistical method was taken as the algorithm,with the median value and the median absolute deviation of the testing results provided by all participating laboratories as the assigned value and the standard deviation for proficiency evaluation,respectively.ResultsThe homogeneity of the medicinal glass infusion bottle samples met the requirements,and the testing ability of the inspection institutions met the requirements of proficiency testing program.Among the 28 laboratories,the testing results of 27 laboratories were rated as satisfactory,with a satisfactory rate of 96.43%,and the testing result of one laboratory was rated as suspicious,with a suspicious rate of 3.57%.ConclusionThe testing results of most laboratories are satisfactory,while the testing ability of individual laboratories need to be improved.The drug administration departments should continue to pay attention to the laboratory ability building and strengthen the business training of laboratory personnel.

关 键 词：能力验证 玻璃输液瓶 线热膨胀系数 均匀性 

分 类 号：R917[医药卫生—药物分析学] R979.9[医药卫生—药学]