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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。
Verification is the basis of GMP implementation and key links, and verification of laboratory equipment, but also the GMP implementation of the difficulties and priorities. For a long time, there were different opinions on the verification requirements of the laboratories of pharmaceutical companies both at home and abroad. Likewise, different administrative agencies also implemented different regulations respectively. The breadth and depth of laboratory instrument validation has been the focus of controversy in the pharmaceutical industry. In January 2008, the USP issued a new monograph on laboratory instrumentation <1058> confirming analytical instruments, setting out the specific rules for this issue. I now introduce this monograph, and summarize the basic requirements for instrument validation in international approvals.