Objective: To standardize the confirmation of metrological verification and calibration results of instruments and equipment in drug testing institutions to ensure that the performance of them meets the application requirements. Methods: According to the provisions of CNAS-CL01-G002:2021 “Requirements on the Metrological Traceability of Measurement Results” and combined with common problems in metrological verification and calibration of instruments and equipment in drug testing institutions. The ways to conduct confirmation of the metrological verification and calibration results of instruments and equipment were discussed. Results and Conclusion: The laboratory should make metrological confirmation in four aspects, the integrity and standardization of verification and calibration certificates, the conformity of the metrological traceability results with the expected use requirements, whether the instrument and equipment need to be adjusted, revised, degraded, and limited in use, whether the verification and calibration results affect the evaluation of the measurement uncertainty of the project. It is recommended that laboratory should establish metrological confirmation operating procedures according to testing standards and technical specifications, and provide adequate training for confirmation stuff to ensure that the metrological confirmation results are valid, and testing data are accurate and reliable.
Ye Qing, Li Haifang, Yin Xuerong, Zhang Jun
. Confirmation of the Results of Metrological Verification and Calibration of Instruments and Equipment in Laboratory[J]. Chinese Pharmaceutical Affairs, 2022
, 36(3)
: 287
-292
.
DOI: 10.16153/j.1002-7777.2022.03.008
[1] 中国合格评定国家认可委员会.CNAS-CL01-G002:2021 测量结果的计量溯源性要求[S/OL].(2021-08-03)[2021-12-10].https://www.cnas.org.cn/rkgf/sysrk/rkyyzz/2021/08/906163.shtml.
[2] 王冠杰,田利,赵海波,等.药品检测机构仪器设备计量分类管理模式的建立及应用[J].中国药事,2014,28(2):163-165.
[3] 李云巧,李睿喆,胡俊华,等.检测实验室如何做好分析仪器的检定校准及其管理(上)[J].中国计量,2017(10):112-114.
[4] 国家质量监督检验检疫总局.JJG 1061-2010 液体颗粒计数器[S].2010.
[5] 中华人民共和国药典:四部[S].2020:125-126,61-65,115,234,39-40,160-165,178-181.
[6] 刘俊杰,张文阁,胡向军,等.JJG 1061-2010《液体颗粒计数器》检定规程解读[J].中国计量,2011(11):120-122.
[7] 中华人民共和国药典:一部[S].2005.
[8] 国家质量监督检验检疫总局.JJF 1290-2011 微粒检测仪校准规范[S].2011.
[9] 李云巧,李睿喆,张金萍,等.如何做好分析检测仪器检定校准结果的确认[J].中国计量,2018(5):91-93.
[10] 国家质量监督检验检疫总局.JJG 705-2014 液相色谱仪 [S].2014.
[11] 国家市场监督管理总局.JJG 119-2018 实验室pH(酸度)计[S].2018.
[12] 中国食品药品检定研究院.中国药品检验标准操作规范 [M].北京:中国医药科技出版社,2019:258-263.
[13] 国家质量监督检验检疫总局.JJF 1030-2010 恒温槽技术性能测试规范[S].2011.
[14] 中华人民共和国国家卫生和计划生育委员会.GB 5009.4-2016 食品安全国家标准食品中灰分的测定[S].2017.
[15] 邹丽,马静,别小琳,等.浅议检验检测机构在做好计量证书确认中应注意的问题[J].计量与测试技术,2020,47(4):104-105.
[16] 国家质量监督检验检疫总局.JJG 178-2007 紫外、可见、近红外分光光度计[S].2008.
[17] 国家食品药品监督管理总局.总局关于发布药物溶出度仪机械验证指导原则的通告(2016年第78号)[EB/OL].(2016-04-29)[2021-11-17].https://www.nmpa.gov.cn/directory/web/nmpa/xxgk/ggtg/qtggtg/20160429160201240.html.
[18] 李孜琮.检定校准证书在检测实验室的应用分析[J].中国计量,2018(8):30-32.
[19] 国家质量监督检验总局.JJF 1001-2011 通用计量术语及定义[S].2011.
[20] 江长清,谈益妹,樊国彪,等.检验检测机构仪器修正因子的应用探讨[J].中国卫生检验杂志,2020,30(12):1532-1533.
[21] 李晓东,李卓.谈谈检定校准结果修正信息的正确应用 [J].农机质量与监督,2020(10):30-31.
[22] 郝晓敏,潘艳萍,王增田,等.实验室纸张检测设备检定校准结果的确认与应用[J].中华纸业,2020,41(22):43-47.
[23] 国家质量监督检验检疫总局.GB/T 19022-2003 测量管理体系测量过程和测量设备的要求[S].2003:10.
[24] 李毅军,王洪礼.浅析计量确认在实验管理中的应用 [J].中国检验检测,2020(3):55-57.
[25] 中华人民共和国认证认可行业标准.RB/T 214-2017 检验检测机构资质认定能力评价检验检测机构通用要求 [S].2017.
[26] 中国合格评定国家认可委员会.CNAS-CL01:2018 检测和校准实验室能力认可准则[S].2018.
[27] 国家市场监督管理总局.检验检测机构监督管理办法(总局令第39号)[EB/OL].(2021-04-23)[2021-12-10].http://www.cnca.gov.cn/zw/bmgz/202105/t20210513_65129.shtml.
