Within Umetrics PAT Suite, there are tools for calibration of models for prediction of quality metrics. Also, there are diagnostics for identification of parameters that have a critical impact on this quality. In pharmaceutical batch processes, the trajectory of batches from initiation to completion can be summarized into a multivariate signature, or fingerprint (see also “Real-time process monitoring”).
The multivariate prediction models produce additional side benefits including:
• Identification of critical parameters
• Analysis of process variation
• Evaluation of the need for additional analytical equipment