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
          Quality Metrics  for Drug ManufacturingPharmaceutical Quality Resources Quality Metrics  for Drug Manufacturing
  
  	
    Share
    Post
    Linkedin

    Email
    PrintWhat are Quality Metrics?

For pharmaceutical manufacturing, quality metrics are an objective way to measure, evaluate, and monitor the product and process lifecycle. Quality metrics data may lead to higher levels of safety, efficacy, delivery, and performance.

Quality metrics are used throughout the drug and biological product industry to monitor processes and drive continuous improvement efforts in manufacturing. Effective use of quality metrics is one characteristic of robust site Quality Management Maturity (QMM).

Why are Quality Metrics Important?

The minimum standard for ensuring that a manufacturer’s products are safe, effective and of sufficient quality is compliance with current good manufacturing practice (CGMP) requirements.  CGMP compliance alone, however, does not indicate whether a manufacturer is investing in improvements and striving for sustainable compliance, which is the state of having consistent control over manufacturing performance and quality. Sustainable compliance is difficult to achieve without a focus on continual improvement.

An effective Pharmaceutical Quality System (PQS) ensures both sustainable compliance and supply chain robustness. Quality metrics can contribute to a manufacturer’s ability to develop an effective PQS because these data provide insight into manufacturing performance and enable the identification of opportunities for updates and innovation to manufacturing practices. Quality metrics also play an important role in supplier selection and can inform the oversight of contract activities and material suppliers, as well as help determine appropriate monitoring activities to minimize supply chain disruptions.

Quality metrics data from establishments can also have utility to the FDA.

Assist in developing compliance and inspection policies and practices.
	Improve prediction and possibly mitigation of future drug shortages, while encouraging the pharmaceutical industry to implement innovative quality management systems for manufacturing.
	Enhance FDA’s risk-based inspection scheduling, reducing the frequency and/or length of routine surveillance inspections for establishments with quality metrics that suggest sustainable compliance.
	Provide ongoing insight into an establishment’s operations between inspections.How Can Quality Metrics be used at FDA?

As part of FDA’s ongoing adoption of risk-based regulatory approaches, the agency is proposing to develop and implement a Quality Metrics Reporting Program to support its quality surveillance activities. Under this program, the FDA intends to analyze the quality metrics data submitted by establishments to:

obtain a more quantitative and objective measure of manufacturing quality and reliability at an establishment;
	integrate the metrics and resulting analysis into FDA’s comprehensive quality surveillance program; and
	apply the results of the analysis to assist in identifying products at risk for quality problems (e.g., quality-related shortages and recalls).Background on FDA’s Quality Metrics Program

In 2004, FDA issued the report “Pharmaceutical CGMPs for the 21st Century – a Risk-Based Approach,” describing FDA’s intent to implement a modern, risk-based pharmaceutical quality assessment system.

In 2012, with the passage of the Food and Drug Administration Safety and Innovation Act, FDA was given the authority to collect pharmaceutical manufacturing records and information from regulated industry as part of FDA’s risk-based oversight.

In 2013, FDA requested public input on the use of quality metrics data to evaluate product manufacturing quality as part of an effort to understand the underlying causes of product shortage (78 FR 9928).

In 2014, FDA gained additional insight when the Brookings Institute collaborated with FDA to convene an expert workshop, “Measuring Pharmaceutical Quality through Manufacturing Metrics and Risked-Based Assessment,” which provided an opportunity for pharmaceutical manufacturers, purchasers, regulators, and other stakeholders to discuss the goals, objectives, and challenges for a pharmaceutical quality metrics program.

In July 2015, FDA issued the draft guidance Request for Quality Metrics (80 FR 44973), which described a proposed mandatory program for product-based reporting of quality metrics.  Under this program, manufacturers would have submitted four primary metrics.  Stakeholder comments on the guidance included concerns regarding the burden associated with collecting, formatting, and submitting data at a product level across multiple establishments; technical comments on the proposed metrics and definitions; and legal concerns regarding the proposed mandatory program.  Stakeholder commenters also suggested a phased-in approach to allow learning by both industry and FDA.

In response to this feedback, FDA published a revised draft guidance in November 2016 entitled Submission of Quality Metrics Data (81 FR 85226).  The 2016 guidance described an initial voluntary phase of the QM Reporting Program, with participants reporting data either by product or establishment, through an FDA submission portal.  FDA removed one of the four metrics from the 2015 draft guidance and requested submission of the remaining three key metrics.  This 2016 guidance also described how FDA intended to utilize the submitted data.  Commenters requested a better understanding of the value and utility of the data to be submitted to FDA and how FDA would measure success of the program.  Commenters also expressed a preference for a pilot program to gather industry input before implementing a widespread Quality Metrics Reporting Program.

In Federal Register notices issued in 2018, FDA announced the availability of two pilot programs, a Quality Metrics Site Visit Program (83 FR 30751) and a Quality Metrics Feedback Program (83 FR 30748) for any establishment that had a quality metrics program developed and implemented by the quality unit and used to support product and process quality improvement. Additional information and lessons learned by FDA can be found on the FDA Quality Metrics Reporting Program; Establishment of a Public Docket; Request for Comments.

In March 2022, FDA established a docket to solicit comments on changes to FDA’s previously proposed Quality Metrics Reporting Program This notice describes considerations for refining the Quality Metrics Reporting Program based on lessons learned from two pilot programs with industry that were announced in the Federal Register in June 2018, a Site Visit Program and a Quality Metrics Feedback Program, as well as stakeholder feedback on FDA’s 2016 revised draft guidance for industry Submission of Quality Metrics Data.  Stakeholders should submit either electronic or written comments by **June 7, 2022**.

Current FDA Resources

Food and Drug Administration Quality Metrics Reporting Program: Establishment of a Public Docket
	Quality Metrics Maturity (QMM)Historical FDA Resources

Brookings Meeting: “Measuring Pharmaceutical Quality through Manufacturing Metrics and Risk-Based Assessment” (May 2014)
	CDER SBIA Webinar – Draft Guidance for Industry: Request for Quality Metrics (July 2015)
	Request for Quality Metrics: Draft Guidance for Industry (July 2015)
	Quality Metrics Public Meeting (August 2015)
	Quality Metrics, Technical Conformance Guide (Version 1.0, June 2016)
	Business Operation and Dosage Forms Data Standards
	CDER Small Business and Industry Assistance article: FDA’s Quality Metrics reporting program: Submission of Quality Metrics Data (November 2016)
	CDER SBIA Webinar - Revised Draft Guidance for Industry: Submission of Quality Metrics | Webinar slides (November 2016)
	Submission of Quality Metrics Data: Revised Draft Guidance for Industry (November 2016) | Federal Register Notice of Availability (November 2016)
	FDA Quality Metrics Feedback Program (June 2018)
	FDA Quality Metrics Site Visit Program (June 2018)

                                                                                  Content current as of:
      11/03/2023
              
              
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