基于药品质量控制对检测实验室分析仪器确认研究

Study on Qualification of Analytical Instrument in Testing Laboratories Based on Pharmaceutical Quality Control

目的:分析检测实验室分析仪器确认对数据可靠性的重要性,指导检测实验室进行分析仪器确认。方法:综述国内外各有关组织发布的仪器确认法律法规要求及相关规范及指南。详细阐述仪器4Q确认,重点介绍4Q确认中的性能确认,并以常规的高效液相色谱仪为例,探讨其性能确认与检定校准的区别。探讨不同类型仪器性能确认过程中发现的问题。结果与结论:仪器性能的稳定可靠是分析数据可靠性的基础保证,是数据质量的重要组成部分,对实验室内的仪器实施确认是确保仪器性能的重要手段。性能确认是仪器确认过程中的重要组成部分,通过性能确认可以确保仪器性能稳定可靠,减少因仪器原因导致的检验结果偏差。实验室应根据实际情况制订仪器确认规程并进行仪器性能确认,以证明仪器正常工作并适合其预期用途,确保所获得数据的可靠性。

Objective:To briefly analyze the importance of analytical instruments validation for data reliability in analytical testing laboratories, and guide the testing laboratory to perform analytical instrument qualification.Methods:The requirements of instrument qualification laws and regulations issued by various organizations at home and abroad as well as related norms and guidelines were reviewed. The 4Q confirmation of the instrument was described in detail. Performance qualification in 4Q verification was emphatically introduced, and conventional HPLC was taken as an example to explore the differences between the performance qualification and verification calibration. Some problems found in the process of performance qualification of different types of instruments were discussed. Results and Conclusion:The stability and reliability of the instrument performance are the basic guarantee of data reliability, and are significant in the data quality. Implementation of instruments qualification in laboratory is an important means to ensure the performance of instruments.Performance qualification is an important part in the process of instrument qualification. Performance qualification could ensure the stability and reliability of the instrument performance and reduce the deviation of the test result caused by the instrument. The laboratory should formulate the instrument confirmation procedures and carry out the instrument performance qualification according to the actual situation to demonstrate that the instrument is working properly and suitable for its intended use and ensure the reliability of the data obtained.