Method Qualification is used to determine method performance capabilities for parameters such as specificity, linearity, accuracy, and precision as required for an intended application. To generate data that can be statistically evaluated VelaLabs’ general approach is to perform the method by a balanced design by e.g. two operators each on three different days. In general, the following parameters recommended by ICH are investigated: Specificity, Precision (Repeatability / Intermediate Precision), Accuracy, Linearity, Range, Limit of Detection (LOD) and Limit of Quantification (LOQ).
In contrast to method validation, there are no predetermined acceptance criteria; however, there may be minimal method performance capability requirements based on an intended application.