Quality metrics: FDA wants feedback on pared-down program

Regulatory NewsRegulatory News | 08 March 2022 |  By 

The US Food and Drug Administration (FDA) on Wednesday outlined a pared-down plan to collect quality metrics data from drugmakers in an attempt to renew its earlier stalled effort to obtain manufacturing quality data as a means of mitigating potential drug shortages and promoting enhanced quality management in the pharmaceutical industry.
The agency stressed in an announcement that this program would be different from the original quality metrics draft guidance unveiled in 2015, as well as the revised draft guidance issued in 2016.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. (RELATED: FDA releases long awaited quality metrics guidance, Regulatory Focus 28 July 2015; Quality metrics for pharmaceuticals: FDA unveils two new voluntary programs, Regulatory Focus 28 June 2018)
“FDA has applied the lessons learned from the pilot programs and other stakeholder feedback toward refining the QM Reporting Program that was presented in the 2016 revised draft guidance,” said the agency.
The industry objected to the revised quality metrics proposal from 2016 over the burden and high costs in collecting this information, leading FDA to adopt the two voluntary programs two years later. (RELATED: Industry Wants FDA to Hit the Brakes on Quality Metrics Program, Regulatory Focus, 30 March 2017).
Through the feedback, “stakeholders have indicated that different industry sectors may prefer different quality metrics. To provide flexibility to manufacturers, FDA would focus less standardization of quality and definitions,” said the agency’s notice. “Instead, FDA would identify practice areas that are critical to ensure sustainable product quality and availability and would permit manufacturers to select a metric(s) from each practice areas that are meaningful and enable establishment to identify continual improvement opportunities.”
FDA explains that adherence to current good manufacturing practice (CGMP) requirements is the “minimum standard” for ensuring safety and effectiveness, “CGMP does not necessarily indicate whether a manufacturer is investing in improvements and striving for sustainable compliance, which is the state of having consistent control over manufacturing performance and quality.”
FDA has identified four areas, and the individual metrics within these areas, as appropriate, 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.


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