3/9/2022 – 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 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a Site Visit Program and a Quality Metrics Feedback Program, as well as stakeholder feedback on FDA’s 2016 revised draft guidance for industry Submission of Quality Metrics Data.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?
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)