中英文 关键工艺参数的定义指南.docVIP

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 (technical limitations) 参数控制的技术能力（技术限制） the uncertainty of the measurement of the parameter (reflected by the standard deviation σ