By Graeme Harland, Head of Quality Assurance, AcuraBio
A strong and compliant quality management system (QMS) serves as the backbone to support any successful biopharmaceutical manufacturing project. QMS acts as a framework for contract development and manufacturing organizations (CDMOs) to manage all aspects of quality including planning, assurance, control, and improvements.
Top CDMOs have QMS procedures, processes, and personnel harmonized to ensure international standards and regional regulations are followed. Although many of these quality processes may seem one-size-fits-all, nuances surrounding how a CDMO onboards and operates will affect the speed, efficiency, and outcome of your projects.
This article explores transparency and transfer considerations, oversight on objective quality and working as a multidisciplinary team, and a phase-based approach.