FDA Quality Management Maturity Program

Drug shortages in the pharmaceutical industry is a significant concern that has far-reaching consequences for the industry, the regulators, the healthcare system, and ultimately the patients. These shortages can be for a variety of factors including manufacturing and quality issues. To this end the FDA embarked on the Quality Management Maturity (QMM) Program, with one of its aims to alleviate drug shortages. The FDA’s Quality Management Maturity Program establishes a framework that acknowledges, and rewards manufacturers committed to mature quality systems. A robust quality management program supports preventing manufacturing errors, optimizing processes, ensuring compliance, and fostering a culture of continual improvement, all of which collectively work towards maintaining a consistent and uninterrupted drug supply chain. This, in turn, ensures the continuous availability of safe and effective drugs, safeguarding patient health, and contributing to a more reliable drug supply chain. The QMM program aims to raise awareness at all levels of management about achieving quality objectives and improving manufacturing site quality and supply chain reliability in drug manufacturing processes. This initiative is based on maturity modelling, and it is designed to help pharmaceutical companies improve their operations while meeting patient needs and corporate goals. It encourages organizations to go beyond regulatory compliance and adopt pre-emptive measures to ensure product quality and availability.

In a recent update, the FDA published CDER’s Quality Management Maturity (QMM) Program: Practice Areas and Prototype Assessment Protocol Development. CDER’s Quality Management (fda.gov). In this document it outlines how a team of assessors will use a standardized assessment protocol in the assessment of an organization to minimize bias and individual subjectivity in the assessments. This protocol will cover five essential practice areas:

1. Management’s Commitment to Quality: Involves management setting the right example, aligning quality objectives with broader organizational goals, providing the necessary resources, and fostering transparent communication channels to create a culture of quality throughout the organization.
2. Business Continuity: Business continuity practices are vital for ensuring operational resiliency, safeguarding against disruptions, and minimizing risks to the pharmaceutical supply chain to maintain a stable drug supply.
3. Advanced Pharmaceutical Quality Systems (PQS): An advanced Pharmaceutical Quality System goes beyond basic quality compliance. It incorporates quality principles such as “quality by design”(QbD) and risk management approaches. This advanced PQS is designed to ensure continued suitability, capability, and reliability of the quality system.
4. Technical Excellence: Effective technical excellence involves the management of information and data. This includes understanding the information needs, capabilities, and limitations of operations. It emphasizes the importance of data-driven decision-making and maintaining data integrity throughout all processes. This ensures that practices are both fit for purpose and contribute to operational excellence.
5. Employee Engagement: Engaged employees, regardless of their level within the organization, take ownership of their responsibilities. They are empowered to identify issues, communicate concerns, escalate problems when necessary, and initiate changes that lead to continuous improvement in processes, procedures, and practices.

The assessment teams will evaluate the practices and quality culture within an organization and at the conclusion of each assessment, participants will receive a report, highlighting areas the organization may wish to consider for continuous improvement. The report may also include benchmarking data without disclosing the identity of organizations participating in the QMM Program. Benchmarking involves comparing the performance and maturity of the participating organization with similar organizations in the pharmaceutical industry that may provide valuable insights into how an establishment compares to others in terms of supply chain reliability, based on specific criteria such as establishment size, product type, and assessment year.

What does QMM look like for industry?

Although not mandatory, the program can be beneficial for the life science industry. One strategic approach to achieving QMM is that it is integral to existing Quality Systems and should not be an additional burden or requirement. Most organizations already have processes and practices aligned with QMM, and achieving higher levels of QMM naturally results from proactive continual improvement efforts. Let us break down the key points of this approach:

1. Alignment with Existing Practices: The approach acknowledges that several organizations already have processes and practices that align with QMM principles to some extent through the implementation of a PQS and incorporation of the ICH Q10 product lifecycle concepts. QMM seeks to build upon these foundations and improve upon them through proactive and continual improvement efforts. This can be achieved by aligning quality policies and objectives with broader business goals, ensuing a robust corrective and preventive action program exists, and advocating for proactive risk management, continual improvement, and a systematic approach to ensure high-quality drug production across the product lifecycle.
2. Culture of Quality: Encouraging a “culture of quality” means that a commitment to quality is embedded throughout the organization. Quality is not just a departmental concern but a fundamental aspect of the business culture, embraced by all employees. This can be achieved by management fostering an environment where employees feel comfortable sharing their ideas, and suggestions for improvement, and engaging employees in continual improvement initiatives and patient safety efforts ensuring they understand the impact of their roles on product quality and patient safety.
3. Quality Metric Program: The use of quality metrics provides a data-driven approach to quality management. Metrics can help organizations identify areas for improvement, track progress, and make informed decisions. The use of leading metrics such as Process Performance Indices (CpK/PpK), Right First Time Rate, and CAPA Effectiveness, versus lagging metrics provide early signals or trends that can predict potential issues in manufacturing processes or the supply chain These indicators offer insights into areas that might develop into problems leading to drug shortages.
4. Long-Term Cost Savings: Investing in a mature and robust Quality Management System and achieving higher levels of QMM can lead to long-term cost savings. By preventing quality issues and disruptions in the supply chain, organizations can reduce costs associated with recalls, remediation, and suboptimal processes.
5. Regulatory Benefits: When an organization demonstrates a robust and mature quality system and practices, and a quality culture through a higher QMM rating, it could potentially lead to reduced inspection frequencies and greater regulatory flexibility.

CAI offers extensive expertise and support for organizations aiming to implement a QMM program. This support includes developing and enhancing a robust PQS, reviewing and refining quality metrics, and providing guidance and a strategic plan for implementing a Quality Culture.