Announced/Unannounced Inspection Pilot Moves Forward
FDA is beginning a pilot program to measure the impact of announced versus unannounced GMP inspections for both domestic and foreign inspections. Speaking at the 3/8 46th International GMP Conference at the University of Georgia in Athens, ORA Office of Pharmaceutical Quality Operations director Alonza Cruse said the two-year pilot was planned to begin just as the Covid-19 pandemic began in 2020. It was delayed until now because most foreign and domestic inspections, except those few that were deemed mission critical, were delayed due to travel restrictions. Domestic inspections are being brought back up to speed and foreign inspections should be in full gear next month absent any areas that begin to struggle with new Covid-19 outbreaks, he said.
Asked what metrics the agency will use to measure the pilot program’s success, Cruse said FDA will assess how it was able to accomplish the inspection, such as whether an unannounced inspection takes longer to conduct than an announced inspection. It will also look to measure whether either inspection led to any significant change in the “compliance outcome of the site or the classification of that site, and we will look at costs but it is not a primary driver of the pilot,” he said.
Cruse also said that agency information technology staff are looking at whether a special portal should be created for companies to submit records requests. The use of record requests grew tremendously during the pandemic and will remain in place as FDA operates under its ongoing hybrid inspection process. “I'm not aware of what the latest rendition of that is, but I can safely say that the agency is looking at it because it's not just records in the pharmaceutical and medical product areas, it’s also records on the food side and other areas within the agency,” Cruse said. “So it's something that is very active, and the chief information officer is working with the respective Centers on how best to deal with that.”
Additionally, Cruse said the pandemic brought new meaning to mutual reliance, mutual recognition and various other information sharing arrangements with international regulators. He said FDA and its counterparts are interested in expanding mutual recognition agreements, where FDA can obtain inspection reports made by other countries. He said the pandemic “highlighted an ever-growing need to expand how we work with regulatory counterparts across the globe, and so that has been an ongoing dialog on how we go about doing some of those expansions… We have also been active in training and meeting with regulatory partners to get a good ‘lessons learned’ from the pandemic… We are going to certainly maintain a high level of information sharing with our regulatory partners.”