Development and in-line validation of a Process Analytical Technology to facilitate the scale up of coating processes

► Raman spectroscopy is used to follow a pharmaceutical active coating process. ► An in-line development strategy was applied for multivariate model building. ► The model is used for endpoint detection at production scale. ► The model was validated according to the European Medicine Agency guideline. ► Robustness and applicability of the method could be shown.