IFPMA Points to Consider for Virtual GMP Inspections – an Industry perspective
The COVID-19 pandemic has resulted in governments imposing measures such as confinement, quarantine orders and travel restrictions that have impacted NRAs in their capacities to perform on-site GxP inspections.
Consequently, a number of NRAs have adopted alternative tools including virtual (or remote) inspections elements to sustain the supply of high-quality medicines to patients. These innovative tools are likely to continue being used post-pandemic.
This paper is based on the biopharmaceutical research-based industry’s experience to date with inspections conducted since the pandemic. It consolidates industry lessons learned from working with these inspection tools. It is meant to complement efforts ongoing in other industry organizations such as EFPIA and PhRMA.
These recommendations can assist in carrying out an efficient and effective virtual inspection and can be developed further as more experience is gained and more data is collected.