- QMM Prototype Assessment Protocol Evaluation Program: On January 25, 2024, the FDA published a Federal Register Notice announcing the opportunity for a limited number of establishments to participate in a program involving the use of a prototype assessment protocol to evaluate Quality Management Maturity (QMM). FDA will accept requests to participate through March 25, 2024.
- Public docket for comments: During September 15 – December 14, 2023, the FDA solicited comments on CDER’s QMM program via a public docket. The comments received will assist the Agency in developing a QMM program for establishments manufacturing human drugs, including biological products, regulated by CDER.
Quality Management Maturity (QMM) Program
FDA’s Center for Drug Evaluation and Research (CDER) is establishing a program to promote quality management maturity (QMM) at drug manufacturing establishments. The QMM program aims to encourage drug manufacturers to implement quality management practices that go beyond current good manufacturing practice (CGMP) requirements. The goals of this program are fourfold:
- Foster a strong quality culture mindset
- Recognize establishments that have advanced quality management practices and acknowledge establishments that strive to continually improve quality management practices
- Identify areas where quality management practices can be enhanced and provide suggestions for growth opportunities
- Minimize risks to product availability to assure reliable market supply
Adopting mature quality management practices supports a more reliable drug supply chain by reducing the occurrence of quality-related failures and improving the ability of establishments to maintain performance during expected and unexpected supply chain disruptions. Integrating business and manufacturing operations with quality practices and technological advancements can help achieve higher levels of maturity. This can optimize manufacturing process performance and product quality, enhance supply chain reliability, and foster proactive continual improvement.
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 CGMP regulations and to develop mature quality management systems.
The Pharmaceutical Science and Clinical Pharmacology Advisory Committee voted unanimously in November 2022 that CDER should establish a QMM program that will help encourage drug manufacturers to achieve higher levels of QMM at their facilities. This program could inform manufacturers about the performance and robustness of their drug manufacturing, giving them insights for improvement toward more mature quality management practices.
- CDER’s Quality Management Maturity (QMM) Program: Practice Areas and Prototype Assessment Protocol Development (August 2023)
- Lessons from CDER’s Quality Management Maturity Pilot Programs (AAPS Journal, January 2023)
- FDA Advisory Committee Meeting (November 2, 2022)
- Benchmarking the Quality Practices of Global Pharmaceutical Manufacturing to Advance Supply Chain Resilience (AAPS Journal, October 2022)
- QMM Public Workshop (May 24 – 25, 2022)
- CDER’s Office of Pharmaceutical Quality White Paper on Quality Management Maturity (April 7, 2022)
- Drug Shortages: Root Causes and Potential Solutions – A Report by the Drug Shortages Task Force (2019)