What You Need to Know About Quality Management Maturity

The introduction of the Quality Management Maturity (QMM) system by the Center for Drug Evaluation and Research (CDER) at the U.S. FDA aims to ensure that drug manufacturers have consistent, dependable, and robust business processes to achieve their quality objectives. How will Quality Management Maturity impact manufacturers, and how will it be implemented?

Quality Management Maturity is the state attained when drug manufacturers have consistent, dependable, and robust business processes to achieve quality objectives and promote continual improvement.

CDER regards this as a further step in its goal of ensuring a “maximally efficient, agile, flexible manufacturing sector that reliably produces high-quality drug products without extensive regulatory oversight.” As part of the QMM initiative, the Office of Pharmaceutical Quality has developed a framework to objectively rate the Quality Management Maturity of pharmaceutical manufacturing sites. There are five levels of rating, which we look at later in this article.

A 2020 FDA report (“Drug Shortages: Root Causes and Potential Solutions”) aimed to identify and provide solutions to the issue of drug shortages within the United States. One of the three root causes of drug shortages noted by the authors of the report was that the market failed to recognize and reward manufacturers for mature quality management systems. Therefore, manufacturers were more likely to keep costs low and seek to meet only the minimum requirements of current Good Manufacturing Practices (cGMPs).

In response, CDER proposed the introduction of a five-level rating system that would inform manufacturers and purchasers about the performance and robustness of the manufacturing facility. Furthermore, in keeping with the initial report’s focus on drug shortages, it would seek to imbue confidence in patients in the availability of drugs.

Quality Management Maturity will benefit the FDA, the industry, purchasers and patients in different ways.

• QMM ratings will inform the FDA about quality management procedures at sites. It will also provide insight into factors that might result in a disruption to manufacturing and drug supply.
• Pharmaceutical manufacturers will stand to make gains in efficiencies and regulatory flexibilities, and companies will be assisted in selecting contract manufacturing facilities.
• The FDA expects that the QMM structure will aid purchasers in their decision-making process and will also ensure that decisions are no longer made based on cost factors alone.
• Patients are expected to see the benefits of less disruption to drug supplies.

cGMP for drugs (as defined in 21 CFR 210/211) is a minimum standard to ensure required controls for manufacturing and facilities. ICH Q10 provides guidance on implementing quality management systems and collecting and monitoring data to manage and improve quality. Quality Management Maturity is effectively implementing ICH Q10 and moving quality management to a high maturity level by collecting meaningful data, predictive analysis, statistics, process capabilities and other tools to prevent quality issues, supply disruptions and drug shortages.

This is beneficial to manufacturers because it results in less regulatory oversight, greater regulatory flexibility, shorter approval times for submissions, a better corporate image, and reduced costs in hosting and managing regulatory inspections. A high level of quality maturity is beneficial to customers due to the lower probability of drug shortages and supply disruptions.

To implement QMM, several steps are required. Steps to achieve Quality Management Maturity include:

1. Ensure that basic requirements are met as per 21 CFR 210/211 for drug products and ICH Q7 for sustainable compliance.
2. Ensure that quality management systems are implemented as per ICH Q10 and are effective.
3. Assess the maturity level of all quality systems and identify strengths and weaknesses.
4. Develop a plan to continuously improve Quality Management Maturity toward stage 5 (optimized).

Participation in QMM is not mandatory. The program was approved by its steering committee on November 2, 2022, and the FDA is now working to finalize their assessment criteria. The program will formally launch in 2023. As usual, NSF will keep you up to date on the issue. Sign up to receive our pharma newsletter and we will send the latest on Quality Management Maturity to your inbox.

Our team of ex-regulators and industry experts are already helping companies with QMM-related issues. They can assist your company no matter where your manufacturing site sits within the five levels of QMM maturity. Book a call with an expert today by completing the form below or by emailing healthsciences@nsf.org.