Pharmaceutical Regulatory Inspection/Enforcement Trends

Since the COVID-19 pandemic began, we’ve seen disruptions to regulatory inspection and enforcement. What has this looked like, and what has been the impact to the pharmaceutical industry? In this e-book, we dive in specifically to the regulatory agencies of the FDA in the U.S. and the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK.

The first article examines observations and trends from the FDA’s FY2020 drug inspections. The second article discusses two unique warning letters that all pharmaceutical and API firms, regardless of their product category, should consider and evaluate. The following article from Madeleine Giaquinto of Greenleaf Health explores the FDA’s COVID-19 Pandemic Recovery and Preparedness Plan (PREPP) Initiative Summary Report and its key takeaways for manufacturers. Next, Kalah Auchincloss of Greenleaf Health muses about the changes that we might expect to see in the FDA’s inspections as the agency begins to shift back to more normal operations. The eBook then examines the FDA’s new guidance on remote interactive evaluations of drug manufacturing and bioresearch monitoring facilities during COVID-19, and shares how to plan, conduct, and conclude a remote interactive evaluation. The last FDA-oriented article details the FDA’s “Resiliency Roadmap” and the FDA’s next steps for inspections.

The e-book then shares two articles of insights regarding the MHRA. The first provides an analysis of MHRA’s latest annual good manufacturing practice (GMP) inspection deficiencies report. The second delves into the top 10 most-cited MHRA GMP inspection deficiencies by annex/chapter in 2019.