FDA moves on with Quality Metrics Reporting Program

Recommendation

13/14 December 2023
Berlin, Germany

Root Cause Analysis
A CAPA Workshop on Successful Failure Investigation

The US Food and Drug Administration (FDA) is trying to revive its somewhat forgotten Quality Metrics Reporting Program. The aim is not only to improve quality management in the pharmaceutical industry, but also to reduce drug supply chain disruptions.

An original draft of this initiative dates back to 2015, which was revised in 2016. In the course of the project, the FDA then carried out visits to various sites as part of a voluntary phase and already asked for feedback. This new document takes into account the lessons learned.

In the industry, there were initially many objections to the agency's plans, especially fears of a high level of effort and the associated high costs. However FDA was supported by the results of the voluntary phase.

Now the FDA is asking for specific feedback on three areas:

• Reporting Levels: should reporting be aggregated at the facility level and would such facility-level reporting facilitate the submission of data on quality metrics by contract manufacturing organisations? How would a product family be defined, should metrics be aggregated?
• Practice Areas and Quality Metrics: are there other areas that should be considered? What about an assessment of the quality culture? Are suggestions made by the FDA not appropriate and what could be considered rather? And other questions about practical implementation.
• Other considerations: are there special considerations for certain product categories (e.g. generics, over-the-counter medicines or biological products)? What would be the optimal frequency for reporting data on quality metrics (e.g. monthly, quarterly or annually and broken down by quarter or month)? Etc.

The deadline for submitting comments is 9 June. The FDA asks stakeholders to justify their comments and support them with examples and further information