COVID-19 has brought unprecedented challenges to quality and supply chain management within the life sciences industry. Drug shortages caused by unprecedented supply and demand pressures continue to be significant challenges for many life sciences companies today and for the general public at large as the pandemic continues to escalate.
The Fragile State of the Pharmaceutical Supply Chains in the US
According to a recent report by the Center for Infectious Disease Research and Policy (CIDRAP), the US domestic pharmaceutical supply chain remains in a state of heightened vulnerability, with almost three quarters of the critical drugs required to treat COVID-19 patients facing significant shortages. The current shortages have brought quality management into the spotlight for many life science organizations and have tightened the focus on issues of quality maturity across the larger pharmaceutical manufacturing value chain.
Beyond supply chain disruption, additional factors including implementation of new public health safety protocols, remote work, disrupted operations, and rapidly changing inventory and demand patterns have put stresses on manufacturers and have impacted quality management programs. The recently announced Pfizer vaccine trial outcomes are indeed promising—but the manufacturing and distribution of a vaccine globally is going to remain challenging against an intensifying pandemic.
The Impact of Quality Maturity in Pharmaceutical Production
From a regulatory standpoint, the US Food and Drug Administration (FDA) has long identified quality maturity in pharmaceutical production as a key focal point and lever to increasing drug supply and availability. The desire to modernize domestic pharmaceutical manufacturing with risk-based quality assessment systems at the core has been a longstanding FDA priority. Amidst the backdrop of the surging pandemic and drug supply vulnerabilities, the FDA Center for Drug Evaluation and Research (CDER) has recently announced the launch of two new voluntary pilot programs to assess quality management maturity (QMM):
- Quality Management Maturity for Finished Dosage Forms Pilot Program for Domestic Drug Product Manufacturers (QMM FDF Pilot)
- Quality Management Maturity for Active Pharmaceutical Ingredients Pilot Program for Foreign Facilities (QMM API Pilot)
These new pilot programs intend to assess the current state of quality maturity in pharmaceutical manufacturing, develop benchmarks for comparison, and serve as a framework for a new rating system for quality maturity among pharmaceutical manufacturers. The deadline for participation in the pilot is Nov 30, 2021, with the pilot expecting to run through December 31, 2021.
According to the FDA:
“Manufacturers that demonstrate QMM operate under an enhanced quality management system that exceeds the minimum standards specified in current good manufacturing practice regulations and focuses on continual improvement. Characteristics of a mature quality management system include, for example, the ability to consistently and reliably deliver quality product over time, operational stability, and a strong quality culture.”
A key aim of the proposed rating system would be to incentivize investment into manufacturing quality management systems across the pharmaceutical industry. For example, domestic manufacturers and foreign API suppliers who disclose quality maturity ratings for facilities could benefit from competitive advantages associated with their differentiated quality profile.
A central goal of both pilots is to characterize and define quality maturity holistically across the entire value chain, including but not limited to supply chain, manufacturing strategy and operations, inventory management, EHS and regulatory compliance, performance management and continuous improvement, risk management, management review and responsibility, planning, workforce management, quality culture, and customer experience.
The Role of These Assessment Criteria
So why are these assessment criteria important? And what does it mean for the broader maturity of quality management systems in manufacturing, particularly with the impact of COVID-19?
These criteria demonstrate the importance of what is often referred to as “big Q” quality, in which quality extends beyond the manufacturing process and contributes to a broader culture of quality across the organization. A world class quality management system should be part of a larger, integrated management system that includes environment, health and safety, risk management, operational excellence, and continuous organizational improvement. Assessing quality maturity in an organization will require examining all these areas, as well as leadership commitment to quality and the ways in which data is shared and analyzed across the entire operational landscape. As COVID-19 continues to alter global markets, understanding the role of quality management in achieving operational excellence, in both the domestic drug supply and the market in general, is going to become more important than ever.
To learn more about our COVID-19 response programs, please click here.