Integrating Quality by Design

A project was done in a pharmaceuticals company which was struggling with inconsistent product quality and lengthy development times due to insufficient process understanding. To address these issues, the project team adopted the Quality by Design (QbD) approach. This involved identifying critical quality attributes (CQAs) and critical process parameters (CPPs), conducting risk assessments, and utilizing design of experiments (DoE) to optimize manufacturing processes. By integrating quality considerations from the outset, the company built robustness into the product design and manufacturing process. As a result, the company achieved improved product quality, reduced batch failures by 30%, and shortened development time by 25%. Benefits included enhanced regulatory compliance, reduced time to market and cost savings from fewer rejected batches.