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The agency promised that this program would be different from the original quality metrics draft guidance unveiled in 2015, as well as the revised draft guidance issued in 2016.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