There was some good news and some bad news to be had at a crowded morning session with Eric Pittman, U.S. Food and Drug Administration (FDA) Program Division Director for the Office of Bioresearch Monitoring Operations in the Office of Regulatory Affairs, at the ACRP 2019 gathering in Nashville today (April 13).
The good news? More than half of attendees said they felt “very” or “pretty well” prepared before they got word the FDA was planning an inspection. The bad news? Nearly a quarter of respondents chose the “Who is FDA?” option.
It bears repeating, Pittman said, that it is critical to “provide training to staff on regulatory requirements, specific protocol requirements, any processes or procedures,” and otherwise “facilitate open communications” with the agency. Further, everyone has to understand “not just the what, but the why compliance matters,” he added.
Pittman offered a number of proven tips to help contend with an FDA inspector before, during, and after they visit. For example, consider conducting mock inspections with staff beforehand. “Sponsor audits are a great tool,” he added.
He also urged attendees to get a sense of FDA inspections by reading relevant warning letters and understanding inspection metrics at https://www.fda.gov/ScienceResearch/SpecialTopics/RunningClinicalTrials/ucm26140 9.htm. It’s also helpful to familiarize yourself with the Investigations Operations Manual (IOM), Pittman said. It’s basically a roadmap for what the inspector is likely to dig into during the inspection. IOM: https://www.fda.gov/ICECI/Inspections/IOM/default.htm
“If nothing else, you should be familiar with Chapter 5,” he advised attendees.
While FDA is onsite, work with the agency to understand the inspector’s scope of inspection and schedule. Help the inspector better understand roles and responsibilities and study conduct at your site (e.g., explain records, organization, and access procedures). “The objective is to ensure investigator and site staff have clear communication and expectations,” Pittman said.
He also offered pointers on how to best operate during the inspection when the inspector is onsite. Be accessible to answer questions and provide copies of documents and other records. If retrieving something will take you time, it’s okay to say so, Pittman stressed. “Say it up front, don’t delay” or stall unnecessarily to cover up the fact. Some things take time to produce, Pittman said. FDA gets that.
The inspector should hold an end of day wrap-up session with you, too. They’re often brief and should give you a sense of what the inspector believes they’ve found so far, where they are in the process, and their plan for the following day.
At the end of the full inspection, schedule a close-out meeting and make sure you include relevant personnel. Find out if the FDA plans to issue a 483 (Warning Letter). If so, are its observations clear to you? Do you have additional documentation not reviewed during the inspection? Do you have a verbal response for the inspector? You aren’t required to make one. “It’s OK at this point to say you need to think about something rather than making a change in policy,” Pittman said.
If there was a 483, it’s wise to respond in writing. Well-crafted responses have “stopped Warning Letters from going out,” Pittman said. Provide explanation if appropriate and describe corrective actions considered and when they will be implemented, including any standard operating procedure revisions and staff training.
Author: Michael Causey