GMP approach to overseas manufacturers of medicines and biologicals during the COVID-19 pandemic
(WorldNews Politics)

The COVID-19 pandemic has created many challenges to the ongoing Good Manufacturing Practice (GMP) regulation of medicine and biological manufacturers. Following the suspension of overseas GMP inspections and QMS audits, a significant amount of consideration was given to the appropriate level of regulatory oversight required to maintain an assurance of product quality without requiring wholesale changes to existing processes. These considerations needed to be agile yet sustainable as the length of time that international travel restrictions remain in place is difficult to predict. Remote GMP Inspections Manufacturers of medicines and biologicals are routinely inspected using a...