Fast-Tracking A QbD Approach

By Mario Becker

QbD starts with an understanding of the quality target product profile. This allows potential critical quality attributes (CQAs) to be established and a risk assessment performed that links material attributes and process parameters to CQAs. By understanding the impact of process parameters on CQAs a design space can be developed in which CQAs will be met. Bioprocess engineers must then implement a suitable control strategy that ensure the process operates with the design space. Continuous improvement activities can be performed throughout the product lifecycle and enhance product quality still further.