Inspections Prioritized to Find Compliance/Data Integrity Issues
Fewer FDA inspections over the past two years have also resulted in fewer data integrity citations at drug manufacturing facilities, but the agency doesn’t think for a moment that industry has rid itself of such concerns. FDA is prioritizing inspections of firms with the highest risk of finding compliance issues, including those that may have data integrity concerns, according to ORA Office of Pharmaceutical Quality Operations director Alonza Cruse. Speaking at a 3/15 International Society for Pharmaceutical Engineering conference in Bethesda, MD, Cruse said domestic inspections have resumed and regular international inspections should start up soon. An inspection priority has been placed on conducting preapproval application-based inspections, as well as inspections at facilities previously inspected and classified as “official action indicated,” and “for cause” compliance follow-up inspections. In June, surveillance inspections will be added to the priority listing.
Cruse said FDA has recently been beefing up staff at its India-based inspections office. Several additional staff have been placed on long-term detail there to help “augment the current staff that is already there. We believe that these measures will certainly not only help us to get back up into a normal cadence with conducting foreign inspections, but also get us back to finding these critical deviations where data integrity issues may occur.” He also said that over the past two years the agency has hired about 80 additional investigators who have been going through a revised training program. “So we have been working to get staff up to speed as quickly as possible regarding the training and other activities,” he added.
Joining Cruse in the discussion was CDER Global Compliance Branch senior policy advisor Brooke Higgins who encouraged industry to “self-report any data integrity issues that you find. By remaining transparent with regulators, we can work together as you identify, assess and address any of these data integrity issues. If we identify data integrity issues during an inspection, then we’re put into this reactive mode rather than a proactive mode. It's also very awkward if we happen to stumble upon the data integrity issues during the inspection if you’re already aware of them, and although you might not mean to hide them, it might appear to be that way.”
ORA consumer safety officer Thomas Arista echoed data integrity concerns, opining that it is unfortunate that people actually engage in such activities, “which would suggest to me… we have an issue here with the quality of the culture of any company that would support this type of activity.” He said data manipulation still occurs and “we still see it happening real time and then we get into a separate conversation… that talks about the cause of this and all the other data that you have in place.”
Health Canada regulatory compliance and enforcement advisor Paul Gustafson concurred that data integrity issues and poor data governance can be found in any sector of pharmaceutical manufacturing. “It can be in production or quality control, and it can be as a result of fraud intentionally or simply arise from poor practice,” he said. He recommended a Pharmaceutical Inspection Co-Operation Scheme document on good data management for industry to use as a guide.