Drug manufacturing in the modern pharmaceutical industry has become increasingly challenging to control, especially after the introduction of live organisms in the development process since critical process parameters and critical factors inherently present high variability.
The use of univariate tools monitoring single variables still is a common way of controlling the limits of key process parameters to maintain the process under control. However, process knowledge is limited when parameters are studied individually. For such reasons, multivariate analysis may help to better understand the processes and discover hidden relationships between variables. As ICH guideline Q8 on pharmaceutical development (2017) recommends, monitoring and analyzing the data from just one data source is no longer an option.