USP对实验室仪器验证技术要求探讨

Discussion of USP Specification for Validation of Laboratory Instruments

验证是GMP实施的基础和关键环节,而实验室仪器的验证,又是GMP实施过程中的难点和重点。很长时间以来,国内和国际对于制药公司实验室仪器的验证要求,存在不同的看法;同样,不同的药政机构也分别执行不同的规定。实验室仪器验证的广度和深度问题,一直是制药行业争论的焦点。2008年1月,USP颁布了关于实验室仪器的新专论〈1058〉分析仪器确认,对这个争论焦点给出了具体的规定。笔者现在介绍这个专论,并总结国际认证中对于仪器确认的基本要求。

Validation is the basis and key step in GMP implement. However, the validation of the instruments used in laboratory is the core and difficult step in GMP implement. Since long times, there have been different opinions in validation requirements for instruments used in company laboratory from China and foreign countries. Moreover, different stipulations are employed in different drug relevant organizations. The width and depth of the validation for instnmaents used in laboratory have been always the controversial problems. In January, 2008, a new general chapter 〈1058〉 analytical instrument qualification was issued by USP, in which some concrete stipulations for this topic were presented. This chapter was introduced in this article, and at the same time, the fundamental requirements to instrument qualification in international validation were summarized.