The role of senior leadership in quality management and maturity

Synopsis

The Pharmaceutical Quality System (PQS) is always a focus of regulatory inspections, whether that be documentation, deviations, changes or CAPA effectiveness yet it is consistently an area of non-compliance observations. Why? The PQS should be seen as a holistic function with all individuals and teams operating in harmony to identify, impact assess and resolve deficiencies quickly, thereby mitigating future risks. The goal of senior leadership should be to establish a mature quality culture across their organisation. This will achieve lower levels of non-RFT, higher levels of continuous improvement, improved efficiencies and morale, ultimately leading to lower attrition and a better understanding of GMP and risk.