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FDA Quality Metrics

Intro to FDA’s Request for Quality Metrics

Industry News - 4 November 2015

In July of this year, the Food and Drug Administration (FDA) issued a Draft Guidance for Industry entitled, Request for Quality Metrics. Under the FDA’s Safety and Innovation Act (FDASIA), the FDA may require companies to submit records and information described in this guidance prior to, or in lieu of, an inspection. The FDA uses the data to calculate quality metrics to be used to assess the state of the quality system, and the quality of the products manufactured by a company.

The FDA intends to calculate several quality metrics for each product and company. In addition, they will request comments on several optional metrics that may be used as evidence of both the manufacturing process’ robustness and the company’s commitment to quality.

The Guidance document states that, “Manufacturers should use ongoing programs to collect and analyze product and process information to evaluate the state of control of the process.” In addition, the FDA reminds companies that, “The CGMP regulations for human drugs require an ongoing program to maintain and evaluate product and process data that relate to product quality. In order to perform this evaluation, manufacturers should be calculating and evaluating quality metrics on a continual basis.”

Regardless of what changes occur before the Guidance is finalized, this Guidance represents a major change in the authority of the FDA. Under FDASIA, if a firm fails to provide the information requested “within a reasonable timeframe, drugs from the facility may be deemed adulterated… and subject to enforcement action.”

The Guidance reinforces the importance the FDA places on quality metrics. It sets a clear expectation that a company must exercise the due diligence that a quality management system (QMS) can help provide. Under these increasingly stringent regulatory circumstances, it’s perhaps not surprising that we’ve seen a recent upsurge in interest in our EQMS offerings.

Link to Request for Quality Metrics: Guidance for Industry PDF, July 2015
Link to FDA Blog Discussing Quality Metrics


About the Author
Brian Graeff is currently the Head of the Quality Best Practices Unit at SOLABS. Brian’s career in the pharmaceutical industry spans over 40 years during which he held various management positions in Quality Assurance, Quality Control and Production with Sterling Drug-Winthrop Laboratories, AstraZeneca and Sunovion Pharmaceuticals Inc.. Brian retired from Sunovion in 2010, where he served as the VP of Quality Operations. During his career, Brian helped manage many different drug products and API’s with the majority of his experience being with parenteral, respiratory and tablet dosage forms. Brian brings a wealth of experience in pharmaceutical manufacturing, quality management, FDA interactions and CGMP interpretation and implementation to the table.

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