News about GMP/cGMP


US FDA: Gradual restart of surveillance inspections

The US FDA is planning a gradual re-start of on-site surveillance inspections in cooperation with the Centers for Disease Control and Prevention (CDC).

Since March due to COVID-19 only mission-critical inspections abroad as well as domestic for-cause inspections have been carried out. Continuously, alternatives such as the evaluation of company records should still be used as far as possible. Together with the CDC, further action based on scientific data and in accordance with the White House Guidelines for the reopening of the USA is planned. This should ensure that inspections are conducted safely.


FDA: Press release – Coronavirus (COVID-19) Update: FDA updates on surveillance inspections during COVID-19