37 – Establishing and Maintaining a GMP Quality Management System (QMS) (S18E5)

17 min • 24 maj 2025

This episode provides a comprehensive overview of establishing and maintaining a robust GMP Quality Management System (QMS). We define the QMS components, including quality planning, and management review. We highlight the importance of continuous improvement practices in ensuring a dynamic and effective system. Explore how a well-designed QMS integrates all aspects of manufacturing, from personnel training and documentation to audits and risk management.

We discuss the crucial role of leadership commitment in driving a culture of quality throughout the organization. We emphasize the importance of setting clear quality objectives and using performance metrics to monitor progress and identify areas for improvement. Learn how effective QMS implementation ensures ongoing regulatory compliance and fosters a proactive approach to quality management.