Introduction
The pharmaceutical industry is witnessing a paradigm shift in quality management (QM) as risk-based approaches become integral to ensuring compliance and efficiency. With the rise of advanced therapy medicinal products (ATMPs) and cell and gene therapies (CGTs), contract development and manufacturing organizations (CDMOs) are adopting data-driven and digitalized processes to manage quality risks effectively.
A key trend is the implementation of risk-based quality management (RBQM), which prioritizes resource allocation based on potential risks to product quality, moving away from exhaustive documentation processes. Other methods include, leveraging cloud-based systems, AI, and machine learning to monitor quality in real time, prevent deviations and ensure regulatory compliance. Furthermore, advanced technologies such as virtual reality (VR), augmented reality (AR), and automation are being used to enhance training, operational efficiency, and regulatory adaptability.
As stringent regulations evolve, leading CDMOs such as Syngene, are embracing fit-for-purpose quality management strategies to shorten lead times while maintaining high-quality standards.
