
Pharmaceutical Quality Management System: Elements, Structure and Implementation
A pharmaceutical quality management system (QMS) is the set of documented processes, responsibilities and controls that keeps every batch consistent, traceable and compliant with GMP. A working pharmaceutical quality management system covers document control, deviations, CAPA, change control, audits and management review. Inspectors test these areas first, because they show whether quality is practiced on the floor or only written down. What a Pharmaceutical Quality Management System Includes Think of the QMS in pharma as the operating system of a manufacturing site. Production, QC, warehousing, engineering and procurement all run on it. If a deviation occurs, the system says who investigates it.