The Continuous Drug Product Quality by Design (QbD) model aims to ensure consistent product quality from development through to commercial production. One significant hurdle in this process is maintaining information integrity during the technical transfer from R&D to production. Additionally, implementing effective process monitoring within a multivariate design space presents complexities. Despite these challenges, the QbD model strives to optimize and control production processes, ensuring high-quality outcomes and regulatory compliance throughout the drug development lifecycle.
