Skip to main content
          Skip to FDA Search
          Skip to in this section menu
          Skip to footer links


U.S. flagAn official website of the United States government

					Here’s how you know
          			Dot gov**The .gov means it’s official.**Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.
							      SSL**The site is secure.** The **https://** ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. 
			U.S. Food and Drug Administration
				
        Search
            Menu
							
						Search FDA
									
									Submit search 
		Featured
							Contact FDA
	                FDA Guidance Documents
	                Recalls, Market Withdrawals and Safety Alerts
	                Press Announcements
	                Warning Letters
	                Advisory Committees
	                En Español

					Products
            Food
							Drugs
							Medical Devices
							Radiation-Emitting Products
							Vaccines, Blood, and Biologics
							Animal and Veterinary
							Cosmetics
							Tobacco ProductsTopics
            About FDA
							Combination Products
							Regulatory Information
							Safety
							Emergency Preparedness
							International Programs
							News and Events
							Training and Continuing Education
							Inspections and Compliance
							Science and ResearchInformation For
            Consumers
	            Patients
	            Industry
	            Health Professionals
	            Federal, State and Local Officials 
 In this section:

                Pharmaceutical Quality Resources

Pharmaceutical Quality Resources

                        Chemistry, Manufacturing, and Controls Development and Readiness Pilot (CDRP) Program
          Search for Pharmaceutical Quality Documents
          Current Good Manufacturing Practice (CGMP) Regulations
          CDER Quality Management Maturity
          Q&A on CGMP Requirements
          Inspection | Enforcement Resources
          Questions and Answers on Quality-Related Controlled Correspondence Home
          Drugs
          Development & Approval Process | Drugs
          Pharmaceutical Quality Resources
          CDER Quality Management MaturityPharmaceutical Quality Resources CDER Quality Management Maturity
  
  					
	
    Share
    Post
    Linkedin

    Email
    Print**What’s New**

**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.  Thecomments 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 supplyAdopting 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.

QMM History

A multi-agency Federal task force reportedthat 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.

Resources

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)

                                                                                  Content current as of:
      01/26/2024
              
              
Regulated Product(s)
		 DrugsPharmaceutical Quality Resources

          
                        Chemistry, Manufacturing, and Controls Development and Readiness Pilot (CDRP) Program
          Search for Pharmaceutical Quality Documents
          Current Good Manufacturing Practice (CGMP) Regulations
          CDER Quality Management Maturity
          Q&A on CGMP Requirements
          Inspection | Enforcement Resources
          Questions and Answers on Quality-Related Controlled Correspondence
 
 Footer Links
    FDA Archive
          About FDA
          Accessibility
      Visitor Information
          Website Policies / Privacy
          No FEAR Act
          Vulnerability Disclosure Policy
      FOIA
          HHS.gov
          USA.gov
    Contact FDA
      Follow FDA on Facebook
      Follow FDA on X
      Follow FDA on Instagram
      Follow FDA on LinkedIn
      View FDA videos on YouTube
      Subscribe to FDA RSS feeds
    FDA Homepage
    Contact Number
      1-888-INFO-FDA (1-888-463-6332) Back toTop