Drugs

CDER Technical Guide on Quality Metrics

CDER has released a “Quality Metrics Technical Conformance Guide” that is intended to serve as the reference for implementing its earlier draft FDA guidance on Request for Quality Metrics. “FDA expects that quality metrics calculated from data that it collects will provide objective measures that, when used with additional internal data, will provide the agency with indicators of the effectiveness of pharmaceutical manufacturing quality systems,” the guide says.

CDER has said that quality metrics will be input into its compliance database to inform “our understanding of the overall quality across the industry, and identify the outliers to set our inspection priorities. We've had a risk model that we have used for many years and we want to get up several levels in sophistication on that model and have real-time data feeding into that to assess the highest risk facilities.”

The initial quality metrics FDA intends to request will help it calculate the following:

Lot Acceptance Rate = 1 –x (x = the number of specification-related rejected lots in a timeframe divided by the number of lots attempted by the same establishment in the same timeframe).
Product Quality Complaint Rate =t he number of product quality complaints received for the product divided by the total number of lots of the product released in the same timeframe.
Invalidated Out-of-Specification (OOS) Rate = the number of OOS test results for the finished product invalidated by the establishment divided by the total number of OOS test results divided by the total number of tests performed by the establishment in the same timeframe.
Annual Product Review (APR) or Product Quality Review (PQR) on Time Rate = the number of APRs or PQRs completed within 30 days of annual due date at the establishment divided by the number of products produced at the establishment.

“While FDA recognizes the value of quality metrics, we also recognize that individual data points and metrics are not solely indicative of the state of quality of the establishment or products,” the guidance says. “Rather, FDA intends to use quality metrics data in context with other sources of quality data... FDA expects that the initial use of the metrics will be to consider a decreased surveillance inspection frequency for certain establishments. For example, establishments that have highly controlled manufacturing processes have the potential to be inspected less often (as a lower priority for inspection) than similar establishments that demonstrate uncontrolled processes (as a higher priority for inspection). In addition, FDA intends to consider whether these metrics may provide a basis for FDA to use improved risk-based principles to determine the appropriate reporting category for post-approval manufacturing changes.”

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