What is QMM?
Quality management maturity (QMM) is attained when drug manufacturers have consistent, reliable, and robust business processes to achieve quality objectives and promote continual improvement.
Why is QMM Important?
Several Federal agencies have identified that many drugs are not being manufactured as they should because manufacturers do not have incentives to be more than just complying with CGMP regulations and implement quality management systems.
The Center for Drug Evaluation and Research (CDER) proposes the implementation of ‘QMM Ratings’ that will encourage drug manufacturers to improve the quality of the drugs they manufacture continually. Regulators use QMM ratings to determine the performance and robustness of drug manufacturing facilities, and patients will have more confidence in the availability of drugs. QMM rating systems could provide manufacturers with greater flexibility to make manufacturing changes after receiving approval from regulators, motivating them to improve continually.
FDA is working with several organizations and government agencies to develop a voluntary quality management program (QMM) for pharmaceutical manufacturers. This group of experts is assessing and evaluating a QMM rating system for drug manufacturers that will allow them to objectively assess the quality of products manufactured by their facilities and share with the pharmaceutical industry information that is useful in evaluating that system’s performance.
The FDA is developing its Quality Management Model (QMM) program, and stakeholders must understand the obstacles to successfully implementing it. FDA plans to develop a QMM program that includes standard assessment tools, policies, incentives, and communications.
The importance of QMM to:
FDA may use the information gained by reviewing QMMs to make better decisions based on the quality of manufacturing activities at its sites. This will help the agency identify potential risk factors that could cause a supply disruption. This will also provide FDA information on how products and facilities perform and what factors may cause supply disruptions.
QMM rating transparency could enable manufacturers to find ways to enhance the quality of the processes they use to produce drugs, implement the flexibility required by ICH Q12 and make decisions that will benefit them by implementing quality management systems.
Using a system that allows manufacturers to report on QMM rating companies easily, consumers can easily judge whether the sites where they buy drugs are doing a good job of managing the quality of their products. Suppose manufacturers cannot see how quality is managed to provide their customers with accurate cost information. In that case, costs will drive their decisions, but manufacturers will not receive direct rewards for investing in quality to avoid shortages.
Patients and Consumers
Patients will receive safe and effective drugs if the pharmaceutical industry is committed to continually improving its processes. Robustly manufacturing systems reduce recalls and enable us to produce as good as possible drugs.
- CDER’s Office of Pharmaceutical Quality whitepaper on Quality Management Maturity (QMM)
Learn more about the QMM and the FDA’s expectations on assessing the maturity of your Quality Management System in this upcoming webinar: