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为了规范我国检验用仪器设备性能验证工作,加快国内检验机构在仪器设备质量控制和管理方面与国际先进实验室接轨,符合世界卫生组织药品预认证的相关要求,本文首先介绍了关于仪器验证的国际先进的4Q模型理论的基本概念和主要内容;其次,对中国和欧盟液相色谱验证标准进行了详细的梳理和比对,总结了两者之间的异同点;最后,结合我国实际情况,提出改进检测实验室仪器性能验证工作的合理化建议。
In order to standardize the performance verification of testing instruments and equipment in our country, speed up the domestic inspection agencies to be in line with international advanced laboratories in terms of quality control and management of instrumentation and equipment, and meet the relevant requirements of pre-certification of the World Health Organization. This article first introduces the international Advanced 4Q model theory basic concepts and main content; Secondly, the China and the EU liquid chromatography validation standards were detailed combing and comparison, summed up the similarities and differences between the two; Finally, combined with the actual situation in China, put forward Improve the rationalization of testing laboratory performance verification.