Quality management maturity as a driver for achieving pharmaceutical global excellence

Vipul Doshi, Chief Quality and Compliance Officer, Zydus Life Sciences delivered a session on “Quality Management Maturity (QMM): A driver for achieving pharmaceutical global excellence.” His presentation emphasised how QMM can transform pharma operations beyond mere regulatory compliance, paving the way for sustained excellence, supply chain resilience, and business success. 

Doshi described QMM as the integration of business operations, manufacturing processes, and advanced quality practices to optimise product quality and drive improvement. He emphasised that a mature quality management system is proactive, datadriven, and continuously improving. 

He explained how adopting mature quality management practices not only enhances regulatory readiness but also aligns with key business objectives, including supply chain reliability, business continuity, and customer satisfaction.

Doshi outlined the five pillars of QMM assessment, covering areas such as management review, resource management, CAPA activities, patient impact understanding, and supply planning. He stressed that QMM promotes robust pharma quality systems (PQS), technical excellence, empowered employee engagement, proactive risk management, and a resilient business strategy.

A significant part of his talk focused on building a strong quality culture, characterised by leadership commitment, effective communication, continuous learning, and proactive risk management. He emphasised that employee engagement and a quality first mindset across all organisational levels are vital for achieving higher levels of QMM. 

The session also explored the challenges associated with QMM implementation, such as defining clear scope, integrating quality principles into decision-making processes, understanding supply chain maturity, and ensuring that investments translate into tangible quality improvements.

Doshi provided insights into the proposed QMM assessment protocols being piloted by the FDA, including on-site or hybrid evaluations and benchmark reports to help establishments identify areas for continuous improvement. 

Concluding his session, he reiterated that ‘Quality is not a destination; it’s a journey of continuous excellence.’ He urged pharma companies to view QMM not merely as a compliance exercise but as a strategic enabler for global leadership, patient trust, and long-term sustainability.