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  1. Pharmaceutical Quality Resources

CDER Quality Management Maturity

What's New

  • The AAPS Journal published a paper titled: Lessons from CDER’s Quality Management Maturity Pilot Programs.  This paper describes FDA’s QMM pilot programs and the important lessons learned about the establishment QMM assessment process, scoring approach, assessor behaviors, and perceptions of the assessment questions, reports, and ratings.
  • The AAPS Journal published a paper titled: Benchmarking the Quality Practices of Global Pharmaceutical Manufacturing to Advance Supply Chain Resilience.  This paper, based on the FDA funded Dun & Bradstreet Quality Benchmarking Study, shares findings that the implementation level for selected quality management practices correlates positively with certain Key Performance Indicators.
  • Pharmaceutical Science and Clinical Pharmacology Advisory Committee Meeting On November 2, 2022, the PSCP advisory committee discussed the CDER QMM program. The committee considered the impact that a QMM program would have on the pharmaceutical industry, drug shortages, and supply chain resiliency. FDA sought input to determine if experts from academia and industry support the development of a CDER QMM program to incentivize investments in mature quality management practices. The committee unanimously voted in favor of a CDER establishing a QMM program.  Please visit the meeting page for event materials.

What is QMM?

Quality management maturity (QMM) is the state attained when drug manufacturers have consistent, reliable, and robust business processes to achieve quality objectives and promote continual improvement.

Why is QMM Important?

A multi-agency Federal task force reported that a root cause for many drug shortages is the absence of incentives for manufacturers to strive for more than simply meeting current good manufacturing practice (CGMP) regulations and to develop mature quality management systems.

CDER has proposed the development of a rating system that will help incentivize drug manufacturers to achieve higher levels of QMM at their facilities. A QMM rating system could inform regulators and purchasers about the performance and robustness of drug manufacturing facilities and give patients increased confidence in the availability of quality drugs. QMM ratings could also support increased flexibility for manufacturers to make post-approval manufacturing changes with less regulatory oversight, incentivizing continual improvement.

Operationalizing a voluntary QMM rating program for pharmaceutical manufacturers requires a collaborative and transparent partnership between FDA, industry, and other stakeholders. FDA has formed a multidisciplinary, multi-Center working group to facilitate the development of a QMM rating program. In developing the framework, FDA is considering standardized assessment tools, policy approaches, industry incentives, transparency, and communications.  FDA is actively developing the QMM program and will continue to engage with stakeholders to identify elements necessary to achieve a successful program.

FDA is committed to ensuring that high-quality pharmaceuticals are available for patients and consumers, and that the U.S. public has confidence in each dose of medicine. A QMM rating system will foster a more robust drug supply chain and greater commitment to quality in pharmaceutical manufacturing.

Why QMM is Important to...

Patients and Consumers

Patients and consumers will have more reliable access to high-quality drugs when industry has a stronger commitment to continual improvement. Mature quality systems support robust manufacturing processes and lead to fewer recalls and quality-related drug shortages. Improving quality management maturity can also lead to reduced costs and greater customer satisfaction.

Industry

Transparent QMM ratings could empower manufacturers to identify ways to improve the effectiveness of their pharmaceutical quality systems, realize regulatory flexibilities described in ICH Q12, inform selection of contract facilities, and obtain efficiency gains (e.g., speed, throughput, supply timeliness) from investing in quality.

Purchasers

A transparent rating system could also inform purchasers about the maturity of quality management practices at sites where they purchase drugs. Without the transparency generated by QMM ratings, there is risk that price will continue to be the key market driver, especially for generic drugs, without direct reward for manufacturers who actively invest in quality to avoid future shortages.

FDA

FDA will benefit from QMM ratings by being more informed about the quality management practices at sites which will facilitate more robust risk-based decision-making (e.g., resource allocation decisions and regulatory flexibility). This would also provide additional insight into the state of quality for products and facilities and help to identify factors that can lead to supply chain disruptions.

What is the Relationship Between Quality Metrics and Quality Management Maturity (QMM)?

CDER has long recognized the value of quality metrics for both FDA and industry. FDA’s Quality Metrics Program intends to gather data on certain key metrics to incentivize continual improvement and support risk-based scheduling of drug manufacturing facility inspections. In these ways, the effective use of quality metrics is a key component of robust QMM program.

Resources

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