FDA and Industry Quality Metrics Initiatives Are Paving the Way to Manufacturing and Regulatory Advancements

Three FDA quality metrics initiatives – involving site visits, industry feedback, and academic research – are expanding the understanding of how metrics can be most effective in advancing pharmaceutical quality and culture and preventing process failures and product shortages, while streamlining regulatory oversight.

In June 2018, FDA’s Office of Pharmaceutical Quality (OPQ) announced that it was launching the new site visit and feedback programs “in response to stakeholder requests for continued dialogue on quality metrics and to provide methods for industry to inform FDA’s use of quality metrics in the future.”

Fifteen companies of varying types, including manufacturers of innovator, generic, OTC, and bulk drugs participated in the site visit program. The visits, which brought FDA staff into the facilities, were completed through the fall of 2019.

The learnings from these visits are now being assessed in the context of the other data and input FDA has available to better understand how the different types of operations are deploying metrics, and how the results correlate with quality outcomes, in the effort to better focus the agency’s inspectional resources.

The companion feedback process, which includes face-to-face meetings with FDA at agency headquarters, is also intended to draw in the experience of drug manufacturers that have implemented quality metrics programs. At the end of August 2019, FDA extended the deadline period for companies to apply until the end of December. [Links to the mid-2018 announcement of the site visit and feedback programs and to the feedback extension are provided below.]

[The story continues for subscribers HERE.  Nonsubscribers can get information on individual IPQ subscriptions and organization-wide licenses by contacting Karen Bertani (Jonathan@ipq.org).]