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FDA’s Team-Based Inspection Program Taking Shape

October 12, 2015

The FDA’s new team-based inspection program is starting to take shape with a steering committee led by high-ranking FDA officials and three subgroups.

The three subgroups are the Pre-Approval Inspection group, the Surveillance Inspection group and the tentatively named For-Cause Inspection group. Tentative scoring systems, investigator training, IT systems and investigator questions have been drafted for the first two groups, while the for-cause group’s functions are being developed, said Russell Wesdyk, acting director of OPQ’s Office of Surveillance.

Wesdyk spoke during a session last week at the FDA/Product Quality Research Institute Conference on Advancing Product Quality in Bethesda, Md.

The PAI and Surveillance groups have conducted pilot inspections, and more are planned, Wesdyk said. At this time, there are no plans for the for-cause group to conduct pilot inspections, as the pilots for the other two groups may be enough, he said. The pilot program is also testing a new IT system to support investigators while on site.

Once fully implemented, PAI will be tasked with performing inspections whose observations inform premarket review decisions. The surveillance group will observe the state of quality in a facility to determine quality risk and perform routine inspections, Lawrence Yu, deputy director of the Office of Pharmaceutical Quality, said. The for-cause inspections will be handled by ORA and look for evidence of cGMP violations to support enforcement actions.

Observations made in the PAI or surveillance inspections could trigger escalation or transition into for-cause inspections, Yu said.

The New Inspection Protocol Project Steering Committee is co-chaired by Theresa Mullin, director of CDER’s Office of Strategic Operations, and Ellen Morrison, assistant commissioner for operations in the FDA’s Office of Regulatory Affairs. — Kellen Owings