13/14 December 2023
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:
The deadline for submitting comments is 9 June. The FDA asks stakeholders to justify their comments and support them with examples and further information