What is QMM?

Quality management maturity 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 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 drugs. QMM ratings could also support increased flexibility for manufacturers to make postapproval 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. This working group is developing a framework to objectively assess and rate the QMM of manufacturing sites through the integration of interactive site assessments and relevant intelligence pertaining to the site’s state of quality.

In developing the framework, FDA is considering standardized assessment tools, policy approaches, industry incentives, transparency, and communications. As FDA has started to develop the QMM program, engaged stakeholders have started to identify key challenges to overcome to realize a successful program.

Why QMM is Important to...

FDA

FDA will benefit from QMM ratings by being more informed about the quality management practices at sites which will facilitate 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 disruption.

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 cost will continue to be key market drivers, especially for generic drugs, without direct reward for manufacturers who actively invest in quality to avoid future shortages.

Patients and Consumers

Patients and consumers will have more reliable access to drugs when industry has a stronger commitment to continual improvement. Robust manufacturing processes lead to fewer recalls and fewer quality-related drug shortages.

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

Quality metrics are used throughout the pharmaceutical industry to monitor quality control systems and processes.

CDER has long recognized the value of quality metrics for both FDA and industry. FDA’s Quality Metrics Program is intended to gather data on certain key metrics to, among other things, incentivize continual improvement and support risk-based scheduling of drug manufacturing facility inspections. For establishments with quality metrics that suggest sustainable compliance there may be a decreased inspection frequency. Multiple industry trade organizations have also recognized the value of quality metrics, developing programs and hosting training courses for members.

The effective use of quality metrics is a key component of robust QMM program. For example, quality metrics information could be more routinely submitted to FDA to bolster and support ongoing confidence in the QMM rating of a site.