Quality Metrics for Drug Manufacturing
What's New:
3/9/22 – FDA established a docket to solicit comments on changes to FDA’s previously proposed quality metrics reporting program (QM reporting Program).
- This notice describes considerations for refining the QM 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a Site Visit Program and a Quality Metrics Feedback Program, as well as stakeholder feedback on FDA’s 2016 revised draft guidance for industry Submission of Quality Metrics Data.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.
What are Quality Metrics?
Quality metrics are used throughout the drugs and biologics industry to monitor quality control systems and processes. Modern manufacturing includes robust quality metrics programs as a foundation for continual improvement of product and process quality. Quality metrics are one element of companies’ commitment to quality culture.
Why are Quality Metrics Important?
The Pharmaceutical Quality System (PQS), a management system to direct and control a pharmaceutical company with regard to quality, provides key elements of assurance and oversight necessary for pharmaceutical manufacturing and quality control laboratory processes throughout the entire product lifecycle, from development through commercial manufacturing. It ensures that quality drugs are available when patients need them.
We have observed examples and also have data which demonstrates that by adopting a quality measurement program, companies improve their overall quality systems. We have also observed early adopters who have integrated robust quality measurement programs in their good business practices with the goal of operational excellence, and ultimately, improved product quality. Since 2016, FDA has been working on a collaborative research project with St. Gallen University to study relevant data-based performance metrics which may be useful in predicting risks to quality prior to failure.
Quality metrics also:
- Help the FDA develop compliance and inspection policies and practices, and inform risk-based scheduling of drug manufacturing facilities, which can result in a decrease in inspection frequency for high performers.
- Improve the Agency’s ability to predict, and therefore, possibly mitigate, future drug shortages
- Provide additional intelligence to inform FDA’s comprehensive surveillance program
- Encourage implementation of state-of-the-art, innovative quality management systems for pharmaceutical manufacturing
FDA is working on implementation of a reporting program so that certain key metrics are reported to the agency. On November 25, 2016, FDA issued a revised draft guidance that includes an explanation of how the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER) intend to utilize submitted data and quality metrics to help ensure that their policies and practices continue to support continuous improvement and innovation in the pharmaceutical manufacturing industry.
Since publication of the 2016 draft guidance, we have been giving presentations, participating on panels, responding to questions, and actively listening to stakeholders. FDA has also initiated a Quality Metrics Feedback Program and Site Visit Program as part of a concerted feedback effort aimed at holistically gathering industry and individual stakeholder comments prior to implementing a widespread reporting program. (see our FAQ for additional details) Regarding the portal for data collection, we remain interested in performing external testing though do not yet have an estimated time for this activity. Further, we have listened to feedback on the Reporters List, as described in the 2016 draft guidance, and do not intend to pursue the List at this time.
We continue to welcome feedback to the docket, including proposed incentives for reporting, which may differ by sub-sector of the industry. Additional comments can be sent to CDER-OS-QualityMetrics@fda.hhs.gov and, per request, will be uploaded to the docket.
Over the past several years, FDA and industry have been discussing how robust quality measurement programs are a foundation of continual improvement of product and process quality and can enable effective and efficient quality systems. FDA issued a draft guidance regarding the collection of quality metrics in July 28, 2015 (“FDA Quality Metrics Program”). In response to comments received in the public docket (FDA-2015-D-2537), FDA issued a revised draft guidance for additional public comment on November 25, 2016 and proposed initiating a voluntary reporting phase of the FDA Quality Metrics Program. In a voluntary reporting phase of the program, FDA expects to learn more about a limited set of quality metrics, associated analytics, and improve the FDA Quality Metrics Program.
FDA expects that owners and operators of human drug establishments that submit voluntary reports will be engaged in the manufacture, preparation, propagation, compounding, or processing of finished dosage forms (FDF) of “covered drug products” or active pharmaceutical ingredients (API) used in the manufacture of “covered drug products.”1
The draft guidance is not focused on voluntary reporting from certain CDER regulated manufacturers (i.e., compounders operating under section 503A or registered as outsourcing facilities under section 503B of the Federal Food, Drug, and Cosmetic Act (FD&C Act)) or CBER regulated manufacturers of blood and blood components for transfusion; vaccines; in vitro diagnostics;2 cell therapy products; gene therapy products; allergenic extracts; or human cells, tissues, and cellular and tissue based products).3
1 The terms “covered drug product” and “covered establishment” are defined in section III.A. of the revised draft guidance.
2 This guidance is not applicable to biological products that meet the definition of a device in section 201(h) of the FD&C Act (21 U.S.C. 321(h)).
3 The guidance does apply to licensed biological products that are plasma derived products, including recombinant and transgenic versions of plasma derivatives.
- Submission of Quality Metrics Data: Revised Draft Guidance for Industry (November 2016) | Federal Register Notice of Availability (November 2016)
- CDER SBIA Webinar - Revised Draft Guidance for Industry: Submission of Quality Metrics | Webinar slides (November 2016)
- CDER Small Business and Industry Assistance article: FDA’s Quality Metrics reporting program: Submission of Quality Metrics Data (November 2016)
- Quality Metrics, Technical Conformance Guide (Version 1.0, June 2016) | Business Operation and Dosage Forms Data Standards
- Request for Quality Metrics: Draft Guidance for Industry (July 28, 2015)
- FDA Voice Blog: ‘Quality Metrics’: FDA’s plan for a key set of measurements to help ensure manufacturers are producing quality medications (July 28, 2015)
- CDER SBIA Webinar - Draft Guidance for Industry: Request for Quality Metrics (July 27, 2015)
- Quality Metrics Public Meeting (August 24, 2015)
- “Measuring Pharmaceutical Quality through Manufacturing Metrics and Risk-Based Assessment,” Engelberg Center for Health Care Reform at Brookings (May 1 & 2, 2014)
- ISPE Quality Metrics Initiative, A Report from the Pilot Project (June 2015) (Wave 1 Report)
- ISPE Quality Metrics Initiative, Quality Metrics Pilot Program (June 2016) (Wave 2 Report)
- FDA Quality Metrics Research Final Report (July 2017) (Report)