Integrating Quality Management Systems (QMS) and Quality by Design (QBD) in the Design and Development of Dexlansoprazole Pellets: Enhancing Product Quality, Consistency, and Regulatory Compliance

The design and development of Dexlansoprazole (DEX) Lansoprazole pellets require a meticulous approach to ensure the final product meets the stringent standards of quality, efficacy, and safety. In this context, Quality Management System (QMS) and Quality by Design (QbD) play pivotal roles. QMS provides a structured framework that ensures compliance with regulatory requirements, facilitates traceability, and promotes continuous improvement throughout the product lifecycle. It emphasizes risk management, ensuring that potential issues are identified early, and corrective actions are implemented proactively. In parallel, QbD focuses on building quality into the product from the outset. It involves identifying critical quality attributes (CQAs), understanding the relationship between formulation variables and product performance, and applying Design of Experiments (DoE) to optimize the formulation and manufacturing processes. By integrating QMS and QbD, the development of DEX Lansoprazole pellets benefits from enhanced product consistency, minimized variability, and a robust control strategy. This integrated approach not only ensures the desired release profile, stability, and patient compliance but also streamlines the development process, reduces risks, and improves the overall quality of the final product. Together, QMS and QbD contribute to the creation of a reliable and effective therapeutic product that meets the highest pharmaceutical standards.