FDA and EMA Inspectors Found Similar Issues at GCP Inspections
(Thursday, June 2, 2022)
A report on inspectional findings during GCP audits by FDA and EMA inspectors found that both regulators found similar issues 9 out of 10 times. The findings of this report, published jointly by the FDA and EMA, support sharing of audit findings between the two agencies to reduce the burden of direct inspections for both. Audits by FDA and EMA are a critical enforcement tool for compliance but due to the extremely large number of sites that need to be verified, it is impossible for either of them to be able to inspect all sites in a timely fashion. The best way to assure compliance within the available resources is to split the inspection responsibilities with other agencies and share the findings, which, in turn can be used to take regulatory actions. However, concerns have been raised about the differences in the inspectional approaches by different regulatory agencies. This survey shows that there is little ground for such concern. Although FDA has signed MOUs for inspections with various regulators in the EU and other regions, and is a member of PIC/S, it still conducts most of its own inspections. Resulting outcome; FDA is far behind on its stated goal of auditing most regulated sites at least once every three years. The survey conducted jointly by FDA and EMA for audits of common sites shows that it may not be necessary for FDA to do all its own audits and that it can rely on the inspections done by other regulators, in this case EMA. However, this survey only discussed clinical trial sites, not the GMP inspections, where the need is even larger and the risk to consumers is higher. Overall, GMP inspections take far greater share of FDA’s resources than the GCP inspections. Similar surveys of GMP inspections are also needed to compare the findings by different regulators. Also, similar surveys must be conducted to compare FDA inspections with those conducted by other regulatory agencies. Although EMA is generally looked at as the closest regulatory agency to the FDA, it is but one of the many regulatory agencies in the world, which strive hard to mimic FDA’s practices. Over the last two decades, FDA has spent significant resources to educate and train regulators in many countries via its international regulatory training programs. The most effective scenario would be where inspections by most regulators are comparable. In an ideal world, most credible regulatory agencies would be able to split the compliance enforcement responsibilities and share findings which would, in turn, save resources for all while increasing the compliance status of the overall industry. With highly inter-connected and inter-dependent pharmaceutical supply chain, it is not just a wish but a necessity. But we are far from it. This report is the one of the first steps in the right direction. Many more similar steps are needed.
Dr. Mukesh Kumar
Founder & CEO, FDAMap
Linkedin: Mukesh Kumar, PhD, RAC