Last week the U.S. Food and Drug Administration (FDA) released draft guidance for the pharmaceutical industry on how it plans to assess manufacturing quality.
The document, Request for Quality Metrics, describes a set of measurements designed to help the agency evaluate the quality of facilities and processes that manufacturers use to make FDA-regulated drugs and biologics, including prescription drugs and certain biological products.
The aim is to develop a more risk-based approach to inspections and to predict, and possibly mitigate, future drug shortages.
The guidance also encourages pharmaceutical manufacturers to conduct robust quality measurements on their own products.
In a blog post on the FDA website, FDA officials Ashley Boam and Mary Malarkey said: “We expect that these measurements will strengthen our efforts to ensure that FDA-regulated medications are not only demonstrated to be safe and effective, but also continually manufactured under strict quality standards.”
The agency anticipates that the initial use of the metrics will be “to consider a decreased surveillance inspection frequency for certain establishments”. For example, facilities with “highly controlled manufacturing processes” may be inspected less often than similar establishments “that demonstrate uncontrolled processes”.
Meanwhile, companies that fail to report requested quality data may elevate their facilities’ predicted risk in the FDA’s prioritization of inspections, leading to earlier inspections.
The agency is inviting patients, prescribers and pharmaceutical firms to submit comments on its quality metrics draft guidance. It will also hold a public meeting on August 24, 2015.
