Measuring Quality System Maturity & Its Significance

The article originally appeared on PQE’s website and is written by Davide Buratti, GxP Compliance Operations Director & Partner @ PQE Group. Read the original article here. 

By Davide Buratti | April 16, 2024

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In our industry, Quality System Maturity (QSM) (HL 1) can best be explained as a depiction of how advanced and effective a pharmaceutical company’s quality management system is. QSM encompasses all the processes and policies an organization implements to ensure its products consistently meet required quality standards and regulatory guidelines from as early as the development stage to the final product distribution. This concept measures the evolution of a company’s quality management from initial, less structured processes to highly refined, systematic practices that incorporate continuous improvement and align closely with industry best practices. Pharmaceutical companies with mature quality systems intact have a better chance of survival and are better equipped to deal with new regulations and market challenges. Such organizations, in practice, exhibit a proactive rather than reactive approach to quality management, which better positions them to anticipate and mitigate potential issues before they escalate. In this article, we will explore Quality System Maturity, Quality Culture(HL3), Quality Management Maturity (HL 2), and why it is crucial for players in the pharmaceutical industry to assess these elements as they grow.

What and How Is Quality System Maturity Measured? 

Given the pharmaceutical industry’s stringent regulatory requirements and the critical impact of its products on public health, measuring Quality System Maturity (QSM) in our industry is by no means an easy task. Quality system maturity should never be interpreted as a destination but rather a continuous journey towards improvement which emphasizes the importance of adaptability, learning, and ongoing enhancement of processes and practices. Regardless of the maturity model employed, each organization should strive for continuous improvement by leveraging the quantitative management of processes and making improvements that boost quality and performance. By so doing, quality becomes ingrained in the organization and becomes a core value that permeates every aspect of its operations. This integration of quality into the organizational culture ensures that every employee understands their role in the quality system and is motivated to contribute to its success, leading to better decision-making and the proactive identification and resolution of issues before they escalate.  

While regulatory and compliance audits, maturity models, continuous improvements, and quality culture do help in assessing an organization’s alignment with Good Manufacturing Practices (GMP), Quality Management Maturity (QMM) provides a more comprehensive framework for understanding and evaluating the depth, effectiveness, and sophistication of an organization’s quality management system.

Quality Management Maturity (QMM) 

In the pharmaceutical industry, Quality Management Maturity (QMM) can be defined as a maturity framework designed to address the unique requirements of drug developers, manufacturers, and distributors to help them achieve the highest standards of quality, efficacy, and safety for their products throughout their lifecycle. The FDA’s Center for Drug Evaluation and Research (CDER) launched the Quality Management Maturity (QMM) Program with the goal of enhancing the quality of pharmaceutical products by providing the necessary support to pharmaceutical companies to help them adopt and implement mature quality management systems. CDER’s ultimate goal is to ensure that drug manufacturers are not just focused on compliance but also consistently produce high-quality medications that meet patient needs. This program emphasizes the importance of a quality culture and continuous improvement within pharmaceutical organizations and the need for more robust manufacturing processes, which result in minimal drug shortages, enhanced drug quality, and improved patient safety. 

Achieving Quality System Maturity Through Quality Culture 

Cultivating a strong quality culture is a fundamental strategy that any pharmaceutical company wanting to advance its Quality System Maturity (QSM) should prioritize. Quality culture requires pharmaceutical companies to prioritize quality in every action, decision, and process, and instill the belief that quality is the responsibility of every employee, regardless of their role and level in the hierarchy. This culture is characterized by a proactive commitment to standards, continuous improvement, and accountability, ensuring that quality is not merely a compliance requirement but a core business value. To embed these values, organizations should commit to quality, set clear expectations, promote open communication, and create the perfect environment for employees to provide feedback and suggest improvements without fear. By focusing on developing a quality culture, pharmaceutical companies can ensure that quality system maturity is not just an objective to be achieved but a fundamental aspect of how they operate. This approach not only meets the immediate demands of regulatory compliance but also positions companies for long-term success in a competitive and highly regulated industry.