A Quality Management System (QMS) is the organizational framework of policies, processes, procedures, responsibilities, and resources established to direct and control a biopharmaceutical or CDMO organization with respect to quality. A robust QMS encompasses document management, change control, deviation management, CAPA systems, training, supplier qualification, internal audits, and management review, and must be implemented in compliance with ICH Q10 and GMP regulations enforced by agencies such as the Food and Drug Administration (FDA) and European Medicines Agency (EMA). An effective QMS is the foundation of regulatory inspection readiness and continuous improvement across all manufacturing and development activities.
