Joanna Ronowicz

Process knowledge discovery tools in compliance with Quality by Design concept
2019-11-30

The significant change in the pharmaceutical quality approach (QbD concept, PAT strategy) and focusing on improving the quality of drug products by reducing variability in the manufacturing process force the use of effective tools to discover process and product knowledge. Continuous process monitoring requires the application of advanced, often non-invasive instrumental analytical techniques that generate a huge amount of process data. Their effective analysis and interpretation is possible thanks to chemometric methods. The appropriate chemometric algorithms allow to detect cause-effect relations between the raw materials properties, process parameters and the drug product quality. The detected relations can be easily translated into accurate and rationally justified technological decisions, leading to manufacturing process optimization and consequently significant improvement of the drug product quality. The effective discovery of process and product knowledge within the QbD concept is possible by means of non-invasive analytical methods generating process data sets which in-depth analysis and interpretation is possible with the use of the appropriate chemometric algorithms.

Keywords: Quality by Design concept, chemometrics, quality management.

© Farm Pol, 2019, 75 (11): 648–655