Process characterization is a systematic experimental study conducted to identify and quantify the relationship between process parameters and product quality attributes, establishing the design space within which a manufacturing process consistently produces a product meeting its critical quality attributes (CQAs). It involves univariate and multivariate experiments — often using Design of Experiments (DoE) approaches — to classify parameters as critical process parameters (CPPs) or non-critical, and forms the scientific basis for the control strategy and process validation plan submitted in regulatory filings in accordance with ICH Q8 and ICH Q11 guidelines.
