精选优质文档-倾情为你奉上Guidance in defining critical process parameters关键参数的定义指南The criticality of a process parameter is an assessment of the probability that it can be consistently and reproducibly controlled within the proven acceptable range (PAR) during routine manufacturing.工艺参数的关键性是指在生产中对可接受范围的持续重复控制的可能性的评估，This probability depends on可能性主要取决于： the robustness of the process parameter (the width of the PAR) 工艺参数的稳定性（可接受范围的宽度） the ability to technically control the parameter (t
