14/15 June 2022
In 2015 the US Food and Drug Administration (FDA) had started an initiative in order to use so-called quality metrics for the planning of their risk-based inspections. The FDA wishes that, after it has come into force, manufacturers will convey defined quality scores to the FDA via an electronic portal. The FDA plans to use these to calculate specific statistics which are supposed to allow for risk-based management and planning by the FDA. The Quality Metrics Initiative then started with a voluntary phase and a revised draft guidance was published in November 2016. However, after this it became somewhat quite. Since the initiative started, industry provided a lot of feedback - fearing additional efforts and expenses.
Now the FDA announced two updated programmes: the Quality Metrics Feedback Program and the Quality Metrics Site Visit Program.
In the introduction FDA is also focussing on the benefits for industry, saying that with implementing a quality measurement program, "companies improve their overall quality systems" and finally product quality.
What is the current status of FDA's Quality Metrics Program?
After the publication of the 2016 draft guidance, FDA was actively promoting the program. The authority was "giving presentations, participating on panels, responding to questions, and actively listening to stakeholders". Now, also with consideration of the various feedback, FDA has initiated these two new programs mentioned above.
Regarding the portal for data collection, FDA remains "interested in performing external testing though do not yet have an estimated time for this activity".
This program introduces in fact two new voluntary phases; one for Type C formal meeting requests and pre-abbreviated new drug application (pre-ANDA) meeting requests and one to gain feedback from those establishments for which Type C formal meetings or pre-ANDA meetings do not apply.
In these meetings, companies can describe in detail their currently used (internal) quality metrics actions including "routine assessment and management oversight of quality culture"!
This program goes even further, and FDA will come to the facilities. The purpose is "to provide experiential and firsthand learning opportunities to FDA staff involved in the development of the FDA Quality Metrics Program and to provide stakeholders with an opportunity to explain the advantages and challenges associated with implementing and managing a robust Quality Metrics Program".
On site, five to ten FDA representatives will then observe "how quality metrics data are gathered, collected, and reported to management".