Inspectorates start again with domestic Inspections

In March, the U.S. Food and Drug Administration FDA announced a postponement of domestic inspections. Despite pausing on-site inspections in the U.S., "investigators have conducted mission critical inspections and other activities to ensure FDA-regulated industries are meeting applicable FDA requirements." Now FDA is restarting on-site inspections based on a COVID-19 Advisory Rating system (COVID-19 Advisory Level). This rating system "uses real-time data to qualitatively assess the number of COVID-19 cases in a local area based on state and national data".

FDA will pre-announce these inspections. FDA's investigators will also be "outfitted with personal protective equipment and equipped with other necessary equipment to carry out their work".

The U.K. Medicines and Healthcare Products Regulatory Agency MHRA also announced a return to on-site Good Practice (GxP) inspections. These inspections might also include hybrid models with on- and off-site activities. MHRA has been discussing necessary arrangements with industry trade associations and the National Health Service NHS. Organisations which will be inspected are "encouraged to discuss arrangements for personal protective equipment, social distancing, engagement with personnel and access to facilities and information at the earliest opportunity". In the transition period, MHRA will continue with its current remote assessment programme.

What about international inspections?

There are currently no official plans for a return to international on-site inspections. Inspectorates continue with remote inspections and distant assessments where indicated.

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