Sophie Depadova, Director Regulatory Compliance, Ropack
The COVID-19 global pandemic is impacting every aspect of life as we know it. As the entire world tries to adjust to this new normal, the pharmaceutical industry is rallying to provide effective vaccines as the speed needed to combat the international threat while also reorganizing its own business models to ensure other medicines continue to reach patients in need. This includes the FDA, which announced in 2020 that the agency was postponing on-site inspections as it considered alternative approaches that would allow for continued regulatory oversight while protecting the safety of facility employees and its inspectors.1 Since that time, domestic inspections prioritized by risk and other factors have resumed under certain conditions; however, on-site foreign inspections not deemed “mission critical” remain temporarily postponed.2 In the meantime, decisions about whether a foreign manufacturing facility is capable of safely and adequately producing a drug product will be based only on the information provided in the inspection application.
Therefore, with so much left to learn about COVID-19 ― including whether we will return to the way things were before or if we should prepare for a future that includes a hybrid of pre- and post-COVID lifestyles ― it is important you understand the expectations of regulators during this unprecedented time and what you can do to facilitate paper-based in lieu of on-site inspections. A deeper knowledge about both could mean the difference between a successful audit and questions and concerns from regulators that lead to costly delays in your program timeline.