FDA Latest Plan for Manufacturing

The US FDA has released the latest plan to collect quality metrics data in an attempt to unstall efforts to obtain manufacturing quality data as a means of mitigating potential drug shortages and promoting enhanced quality management in the pharmaceutical industry.

The agency promised that this program would be different from the original quality metrics draft guidance unveiled in 2015, as well as the revised draft guidance issued in 2016. The newly devised plan is based in the feedback it received through its voluntary quality metrics site visit and quality metrics feedback programs launched in 2018.

The FDA has identified four areas, and the individual metrics within these areas, 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

FDA would like specific feedback on the following: whether reporting should be aggregated at the establishment level; whether reporting at an establishment level would facilitate CMOs submitting quality metrics data; the useful definition of a “product family” for reporting purposes; and the components of a “robust” quality culture if FDA decides to include this as a metric.

FDA also asks whether there should be unique considerations for different product categories, such as generic, over-the-counter (OCT) or biologics and what the optimal frequency for reporting would be.

Additionally, FDA wants input on whether any of the proposed metrics do “not meet the objectives” of the program and what other metrics should be considered.

The deadline for submitting comment is 9 June.

I'd be happy to participate or even coordinate a Division response. Folks interested?

2 Replies

Thank you for the terrific summary. I can bring this up at the next Division meeting later this month if that is ok?


I'll prioritize attending the next meeting