Consistent with the Australian Government’s latest travel restrictions, the Therapeutic Goods Administration (TGA) has suspended all overseas GMP (Good Manufacturing Practice) inspections and QMS (Quality Management System) audits until further notice.
In addition to our commitment to ensuring that overseas manufacturers meet GMP and QMS requirements, we are also mindful of the need to provide transparent information to sponsors affected by these delays. Sponsors immediately affected by the suspension to GMP inspections have been contacted and, where applicable, advised about maintaining the validity of their existing GMP clearances.
Currently there is no impact on domestic inspections and audits; however, we are continuing to monitor the situation and will provide timely updates should there be any change to this position.
The TGA is committed to working with Australian sponsors and manufacturers during this time. Our staff are available to assist via the contact information below:
