Recently, regulatory agencies have put greater emphasis on the need to understand pharmaceutical process, product quality and risk management to ensure that patient needs continue to be met. The United States Food and Drug Administration (FDA) Quality by Design (QbD) initiative encompasses these considerations, building on previous concepts covered in the International Conference on Harmonization (ICH) Q8 Pharmaceutical Development, ICH Q9 Quality Risk Management and ICH Q10 Pharmaceutical Quality Systems.
The QbD approach is meant to drive the drug development process to a proactive and holistic approach based on sound science, while managing risk. This is a deliberate design effort from initial product concept to commercialization meant to provide patients with a safe and effective drug product. As a result, product and process performance characteristics are scientifically designed to meet specific objectives, rather than being derived empirically from performance of test batches. Therefore, the opportunity exists to make changes within the established design space without the need for prior regulatory approval, ultimately reducing the overall approval time and number of product failures.
With that in mind, this article describes how understanding and applying the principles of QbD to analytical methods can ultimately save OINDP manufacturers time and money.