FDA’s Initial Team-Based Inspection Pilot Deemed Success
The FDA’s new proposed team-based inspection program completed initial inspections in its ongoing pilot and was deemed a huge success that helped investigators plan better inspections.
Investigators conducted 10 preapproval inspections and several surveillance inspections under the New Inspection Protocol Program, said Christine Moore, acting director of the Office of Process and Facilities. The results were used only for agency purposes and didn’t factor into regulatory decisionmaking, she said.
While roundly praised, the program won’t be rolled out officially for at least another year, after a second wave of pilots are completed in 2016.
Announced in April, the NIPP inspections will be risk- and rule-based, using expert questions, semi-quantitative scoring to allow for comparisons within and between sites, and a common inspection report structure. Firms that exceed basic compliance will face less frequent inspections.
Firms that were inspected as part of the pilot were not informed in advance, Moore said, adding that the “alpha” pilot was solely for the FDA to see if inspectors could actually do it. The NIPP inspections were conducted in parallel with standard inspections.
The agency wanted to see if investigators were asking the right questions and if they had the proper scoring system and training in place, said Russell Wesdyk, acting director of the Office of Surveillance within the Office of Pharmaceutical Quality. He and Moore spoke at the FDA/Product Quality Research Institute Conference on Advancing Product Quality in Washington, D.C. — Kellen Owings