The Pharma Pulse: The FDA, Mfg, and Quality Metrics

The FDA is seeking industry input on a redirection of its proposed Quality Metrics Program and its reporting requirements for drug manufacturers–both bio/pharma companies and CDMOs. What’s in the new plan?

The FDA is seeking industry input on a redirection of its proposed Quality Metrics Program and its reporting requirements for drug manufacturers–both bio/pharma companies and CDMOs. What’s in the new plan?

The heart of the matter: quality metrics
After a multi-year process to get a Quality Metrics Reporting Program into place, the US Food and Drug Administration is proposing a new direction for the program and seeking input from the industry and other stakeholders on its proposal.

For pharmaceutical manufacturing, quality metrics are objective means of measuring, evaluating, and monitoring the product and process lifecycle to proactively identify and mitigate quality risks, thereby managing operations at higher levels of safety, efficacy, delivery, and performance. Quality metrics are used to monitor quality control systems and processes and drive continuous improvement efforts in manufacturing. Quality metrics are important because failure to update and innovate manufacturing practices and lack of operational reliability (i.e., state of control) can lead to quality problems that have a negative impact on public health, according to the FDA.

Although current good manufacturing practices (CGMPs) are used in the industry, the FDA explains that CGMPs do not necessarily 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 CGMP compliance is difficult to achieve without a focus on continual improvement, said the FDA in its March 9, 2022 notice. “An effective Pharmaceutical Quality System (PQS) ensures both sustainable CGMP compliance and supply-chain robustness. Quality metrics data can contribute to a manufacturer’s ability to develop an effective PQS because metrics provide insight into manufacturing performance and enable the identification of opportunities for updates and innovation to manufacturing practices.”

The FDA further notes that quality metrics also play an important role in supplier oversight and can be used to inform the oversight of outsourced activities and material suppliers as well as appropriate monitoring activities to minimize supply-chain disruptions. Quality metrics data provided by drug manufactures can also assist the FDA in developing compliance and inspection policies and practices to improve the agency’s ability to predict, and therefore possibly mitigate, future drug shortages, and to encourage innovative quality management systems for pharmaceutical manufacturing. For example, quality metrics data can be applied to FDA’s risk-based inspection scheduling, reduce the frequency and/or length of routine surveillance inspections, and provide ongoing insight into manufacturing operations between inspections.

FDA’s efforts to develop a Quality Metrics Reporting Program
As part of FDA’s shift towards a risk-based approach to regulation, the agency proposed to develop and implement a Quality Metrics Reporting Program to support its quality surveillance activities. Under this program, FDA intends to analyze the quality metrics data submitted by drug manufacturing establishments to: (1) obtain a more quantitative and objective measure of manufacturing quality and reliability at an establishment; (2) integrate the metrics and resulting analysis into FDA’s quality surveillance program; and (3) apply the results of the analysis to assist in identifying products at risk for quality problems (e.g., quality related shortages and recalls).

The FDA, along with industry, has been engaged in a multiyear process to develop and come to agreement over common definitions, measurements, and metrics that could be used industry-wide in pharmaceutical and biopharmaceutical manufacturing as part of the Quality Metrics Reporting Program.  The FDA is refining its proposed Quality Metrics Reporting Program based on lessons learned from two pilot programs with industry that were announced 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, Submission of Quality Metrics Data.

A proposed direction for the Quality Metrics Reporting Program
The FDA says it has applied the lessons learned from the pilot programs and other stakeholder feedback toward refining the Quality Metrics Reporting Program. FDA is considering changes to what it first proposed in its Quality Metrics Reporting program. For example, stakeholders’ input indicated that different industry sectors may prefer different quality metrics. To provide flexibility to manufacturers, the FDA would focus less on standardization of quality metrics and definitions. Instead, FDA would identify practice areas that are critical to ensure sustainable product quality and availability and would permit manufacturers to select a metric(s) from each practice area that are meaningful and enable establishments to identify continual improvement opportunities.

In its proposed plan, the FDA has identified four main areas as the basis for the metrics for its program: manufacturing process performance, pharmaceutical quality system effectiveness, laboratory performance, and supply-chain robustness. Its proposal defines these areas and the individual metrics that will fit into each area as a basis of reporting.

Seeking industry and other stakeholder feedback
The FDA is now seeking comments for its new proposed plan, which was published in the March 9, 2022 edition of the Federal Register, the US government’s publication for proposed and final rulemaking. Comments are due June, 2022, which is 90 days post the notice in the Federal Register. The agency is posing a series of questions to gain specific input of the feasibility and utility of these metrics.

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