FDA’s Between a Rock and a Hard Place for its GMP Inspections
(Thursday, February 4, 2021)
It is no secret that FDA stopped all GMP inspections in March of last year due to the pandemic and then resumed highly curtailed risk-based prioritized domestic audits in the Fall. All through FDA used alternate ways to verify GMP compliance for US and foreign manufacturers. But the GAO does not believe it is acceptable and should continue. In a report release this week, GOA concluded that reduced inspections could compromise the quality of the US drug supply chain and suggested that FDA take immediate measures to address the backlog of GMP inspections. Since the pandemic made travel by FDA inspectors hard domestically and impossible internationally, FDA has relied mostly on alternate sources to verify compliance such as past history of the manufacturers and audits by other non-US regulatory agencies. The domestic inspections done by the FDA fell by 87% since March and practically to zero for foreign sites. FDA seems poised to continue these for the near future. But there have been consequences. FDA had not found violations at any of the GMP facilities last year, very atypical for the agency that issued multiple GMP Warning Letters each month. Also, FDA’s assessment of comparability of inspections by most non-US regulatory agencies was never completed so its reliance on those audits is questionable. FDA also had announced prior to the pandemic that it would follow a risk-driven audit practice once it is up to date on all conventional audits. Now due to the backlog, all these plans have to be expedited per the GAO. First, FDA must assess how the backlog impacted its goal to move to risk-driven audits. Second, FDA must complete its assessment of audits by foreign regulatory agencies that it trusts can provide reliable and comparable compliance assessment. This is a tough situation for the FDA. Travel is still restricted globally at least till late summer. While domestically things may improve by the summer, it may be a tall order to complete the backlog while keeping the upcoming calendars. FDA announced that its inspectors located in China and India would start local inspections in those countries at the pre-pandemic pace. So, FDA is trying to get back to normal. The GAO pressure is probably going to push the Agency to further allocate additional resources to GMP inspections. It is surprising that FDA still has not validated tools of remote inspections and video tours, which have become common in the industry over the last year. May be this would push FDA to get the proper technology for that as well. No matter what, the FDA inspectors are going to be very busy for the next 2 plus years trying to deal with the impact of the pandemic.

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AUTHOR               

 Dr. Mukesh Kumar
​ Founder & CEO, FDAMap

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