|
【版权声明】本文与照片均已获原创作者授权推送，供行业朋友学习、借鉴，版权所有。如需转载，可后台留言联系授权白名单，谢谢合作。 【题记】过程确认涵盖了很重要的3个概念，分别是IQ，OQ和PQ。根据GHTF指南，IQ指的是安装鉴定，ＯＱ是操作鉴定，ＰＱ是性能鉴定。这三个概念囊括了过程确认的三个阶段：对使用设备和必要服务规定的一个初始安装证明阶段；对过程产生可接受的结果和建立过程参数限制范围（最坏情况）的操作证明阶段；以及建立长期过程稳定性的性能证明阶段。本文依据GHTF指南,对这三个概念一一解读，欢迎行业朋友们进行讨论和分享。 【Introduction】Process validation is broken down into three important concepts: IQ, OQ and PQ.According to the GHTF guidance, IQ stands for Installation Qualification; OQ stands for Operational Qualification; and PQ stands for Performance Qualification. These three elements represent three distinct phases in the process validation: 1) an initial qualification of the equipment used and provision of necessary services; 2) a demonstration that the process will produce acceptable results and establishment of limits (worst case) of the process parameters; 3) establishment of long term process stability. This article will guide you through these three phases one by one. |
|
|
