Revised US FDA Quality-Metrics program

The US Food and Drug Administration (US FDA) is trying to revive its Quality Metrics Reporting Program, initiative first launched in 2015 with the primary aim to mitigate potential drug shortages and promote improved quality management in the pharmaceutical industry.

An original draft of this initiative raised many objections and especially fears of a high level of effort and the associated high costs by the pharmaceutical manufacturers. Finally, manufacturers were called upon to submit quality data on a voluntary basis. The US FDA has now announced that it has learned from the shortcomings of the original collection plan, from the quality data that have been submitted in the meantime and the feedback from pharmaceutical manufacturers.

The US FDA presented revised plan for collecting quality metrics from drug manufacturers end of March 2022. The US FDA plans to offer manufacturers the opportunity to select one or more quality metrics from each area that are meaningful and allow opportunities for continuous improvement. The US FDA states that compliance with current good manufacturing practice (cGMP) requirements is the “minimum standard” for ensuring safety and efficacy. Still, cGMP does not necessarily indicate whether a manufacturer is investing in improvement and seeking sustained compliance, which is the state of consistent control over manufacturing performance and quality.

The FDA has identified four areas that could deliver appropriate individual quality metrics for reporting:

  • manufacturing process performance; this can include the proportion of lots that were accepted in a given time period as well as the proportion of lots manufactured without a non-conformance.
  • pharmaceutical quality system (PQS) effectiveness; this metric can include the effectiveness of the corrective action and prevention action (CAPA) which can cover the number of CAPAs initiated or closed on time.
  • laboratory performance; this can include the proportion of laboratory test that are completed on schedule.
  • supply chain robustness; this can include the extent to which shipments are delivered on-time and containing the correct quantity.

The deadline for commenting is 9th of June 2022.