The FDA has released a draft of its Request for Quality Metrics, a guide for the pharmaceutical industry. The document contains non-binding recommendations, outlines a set of measurements to evaluate the quality of the facilities and the processes that manufacturers use to make regulated drugs and biologics.
According to the FDA, these quality metrics will be used used to develop compliance and inspection policies and practices in order to improve the FDA’s ability to predict and possibly mitigate future drug shortages. The FDA states that shortages of drugs and biologics pose a significant public health threat causing delays in critically needed care for patients. The agency has discovered that the majority of drug shortages stem from substandard manufacturing facilities, lost batches and quality defects that require remediation efforts.
The new guidance includes an explanation of how the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER) intend to collect data and use quality metrics to ensure that their policies and practices support innovation and continuous improvement in pharmaceutical manufacturing.
The FDA is encouraging some optional metrics around a “quality culture.” Tergus has a “quality culture” throughout the organization, including a fully-implemented Quality by Design (QbD) program. We welcome these new guidelines.