Remote Inspections
All GVP inspections in 2020/21 were conducted remotely due to the ongoing COVID-19 pandemic. Routine inspections were prioritized based on areas of highest risk to patients and public health. In addition, most of the routine inspections were focused on core PV activities (i.e., collection of safety information, management and reporting of adverse drug reactions (ADRs), aggregate reporting, and signal management).
According to the MHRA, remote inspections were made possible by using online platforms that facilitated document sharing and video conferences, which both inspectors and inspected organizations could securely access.
Approaches for Remote Inspections
Several different remote inspection approaches were piloted to determine the most suitable approach. These approaches included inspections consisting entirely of document review, with no interviews with company staff, and inspections spread over several weeks. However, in the end, the preferred inspection mode was a hybrid approach which consisted of targeted interviews conducted remotely and review of data and documents.
“The experience and learnings from the remote inspections completed during the pandemic will likely shape alternative inspection approaches in the future”, says the agency.
