摘要
目的 对药检系统实验室内部质量控制常用方法和评价依据进行总结和分析。方法 对质量控制图、人员比对、设备比对、加标回收、留样再测等5种常用质量控制方法提出具体使用方法,对评价依据提出了参考经验。结果与结论 做好药检系统实验室内部质量控制工作需要灵活运用5种内部质量控制方法,并覆盖到检验/检测涉及的所有领域。
Abstract
OBJECTIVE To summarize and analyze the internal quality control methods and judgment cretiria used by drug quality control laboratories. METHODS The detailed methods of using five kinds of quality control methods, ie, quality control chart, personnel comparison, equipment comparison, recovery test, and retest the retained sample were described. The experience in judgment cretiria for quality control was summarized. RESULTS AND CONCLUSION To meet the demands of quality management in drug control laboratories, the above-mentioned five kinds of internal quality control methods need to be adopted flexibly, and cover all the related test fields.
关键词
内部质量控制 /
质量控制图 /
药检
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Key words
internal quality control /
control chart /
inspection of drug quality
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吴晶.
药检系统实验室内部质量控制常用方法和评价依据[J]. 中国药学杂志, 2016, 51(2): 131-134 https://doi.org/10.11669/cpj.2016.02.012
WU Jing.
Internal Quality Control Methods and Judgment Cretiria Used by Drug Quality Control Laboratories[J]. Chinese Pharmaceutical Journal, 2016, 51(2): 131-134 https://doi.org/10.11669/cpj.2016.02.012
中图分类号：
R927
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参考文献
[1] ISO/IEC 17025:2005-General requirements for the competence of testing and calibration laboratories, Geneva: International Organization for Standardization; 2005.ISO/IEC 17025(General requirements for the competence of testing and calibration laboratories).2005:2020.
[2] THOMPSON M, WOOD R. Harmonized guidelines for internal quality control in analytical chemistry laboratories. Pure Appl Chem, 1995,67(4):649-666.
[3] HOVIND H, MAGNUSSON B, KRYSELL M,et al. Internal Quality Controll-Handbook for Chemical Laboratories . Nt Techn Report, 2011:15-16
[4] SU Z.Principle and methodology of quality control chart and it′s application in instrumental analysis . Phys Test Chem Anal Part B:Chem Anal(理化检验:化学分析册),2005,41(5):343-346.
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