US FDA Published Much Awaited Quality Metrics Guidance

Recently US Food and Drug Administration (FDA) published a draft guidance outlining how it plans to use quality metrics to enhance its potential to perform risk-based inspections and forecast or minimize potential drug shortages.

For the last few years, US FDA has been thinking about methods to enhance drug quality. FDA initiatives were strengthened in 2012 with the introduction of the Food and Drug Administration Safety and Innovation Act, which helped the agency to use performance measures, or quality metrics, “to evaluate a facility’s quality system to ensure product quality.”download

Early this year, after much wait, FDA launched the Office of Pharmaceutical Quality (OPQ) with the objective of “developing a drug quality system as effective as the programs the FDA currently has in place for drug safety and efficacy.”

According to US FDA

Goal of new office is to monitor drug quality throughout a product’s life-cycle, instead of concentrating on pre- and post-market evaluation. Through its surveillance, OPQ will be capable to assist the Office of Regulatory Affairs (ORA) “focus on inspections, to try to minimize quality issues before they result in a recall or the need for an administration action.” This could reduce future problems, since “the greater part of drug shortages stem from quality issues.”

Quality Metrics

Initially, FDA had planned to launch its guidance on quality metrics by the end of 2014, but delays gradually forced back its release.

Since its release, OPQ has been assigned with examining all new drug applications for new and generic products for production quality, in parallel with FDA’s other review bodies.

With the launch of its new draft guidance, Request for Quality Metrics, FDA is providing more information to industry on its method to quality metrics, along with asking industry for its feedback in particular areas that are still being considered.

For organizations with robust quality metrics data, this info could be applied to “decrease the inspection frequency at an establishment.” In situations where the information increases issues, FDA says having the quality metrics data will enable it to “enhance the efficiency and effectiveness” of the investigations. For now, the agency foresees its use of quality metrics to be used mainly for decreasing inspection frequencies.

FDA intends to request that establishments send quality metrics data reports for a one-year time that starts after the agency issues its requests, as specific in the request. Records would be due inside 60 days of the end of the reporting time. The data would be separated in the report on a quarterly basis. Submission would be via the FDA Electronic Submissions Gateway.

The draft guidance document is accessible for review on FDA’s website. Feedback and suggestions can be presented for 60 days on

View the Request for Quality Metrics draft guidance document