药用玻璃颗粒耐水性测定的能力验证研究

Hydrolytic resistance of pharmaceutical glass grains

目的设计和组织药用玻璃颗粒耐水性测定的能力验证项目(No.NIFDC-PT-420),评价参加者对玻璃类包材耐水性测定的能力。方法按照中国合格评定国家认可委员会(CNAS)规定的程序进行样品制备,发样前进行均匀性检验,通过随机发放不同的干扰样品防止数据串通、伪造。采用稳健统计方法,以所有参加者报告结果的中位值为指定值,以标准化四分位距为能力评定标准差,计算z比分数,对上报结果进行评定。结果样品的均匀性符合能力验证项目要求,42家实验室,“满意”结果34家,“可疑”结果4家,“不满意”结果4家,满意率为81.0%。结论本次能力验证客观科学地评估了全国部分实验室药包材的检验能力,部分企业实验室的检测能力还有待提高,药品监管部门须持续关注该类实验室的检验能力建设。

Objective To design and organize the ability test project(No.NIFDC-PT-420)to determine the hydrolytic resistance of pharmaceutical glass grains and evaluate the participants’ability to determine hydrolytic resistance of glass packaging materials.Methods The samples were prepared according to the procedures specified in the China National Accreditation Service for Conformity Assessment.The uniformity was tested before the sample distribution.Different interference samples were randomly distributed to prevent data collusion and forgery.Robust statistical method and z scores were used to evaluate the reported results.z scores were calculated with the median of all participants’reported results as the specified value and the standardized quartile distance as the standard deviation in the ability evaluation.Results The uniformity of the samples met the requirements of the proficiency test.Among the 42 laboratories,34 laboratory results were satisfactory,4 were suspicious and 4 were not qualified.The satisfaction rate was 81.0%.Conclusion This proficiency test objectively and scientifically evaluates the testing ability of pharmaceutical packaging materials in some laboratories in China.The testing ability of some enterprise laboratories need to be improved and drug regulatory authorities should pay attention to the testing ability building in such laboratories.