Very few pharmaceutical and regulatory organizations had a pandemic on their risk management checklist. We traditionally focused on shorter term emergencies like earthquakes and hurricanes. After a few days, we could sweep the floors, mop up the water and reconnect the wires. The movements and proximity of humans was not a factor, and short term postponement of inspections was an effective solution for regulators.
How things have changed in a few short months! Whereas a delay in a FDA GMP inspection of an American plant may be seen as a welcomed break enabling a longer focus on day to day duties, those US plants awaiting a pre-approval inspection and foreign plants requiring inspection before they can ship product to the US have a serious problem.
On April 30, Fierce Pharma reported:
Major Indian pharmaceutical companies are asking the FDA to conduct “desk reviews” or virtual facility inspections during the pandemic in order to “ensure the continuous supply of much-needed drugs in the United States,” according to a letter from the Indian Pharmaceutical Alliance (IPA) obtained by Fierce Pharma. In correspondence dated April 20 to Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research, the alliance asked for virtual reviews of facilities that are new, are slated to produce a new class of drugs or have completed a corrective action plan following a previous inspection failure.
The age of virtual inspections has dawned. Australia’s Therapeutic Goods Administration is conducting domestic good manufacturing inspections remotely in place of on-site inspections during the COVID-19 pandemic and many others could follow suit. While most inspections are likely to return to their classical approach at some point in the future, remote inspections may achieve a permanent foothold. Given resource constraints of regulators around the world, we were heading in this direction anyway. The pandemic has rocketed us into the future, and we need to diligently prepare for the brave new world of remote inspections.