TGA launches shorter Surveillance Inspections

Starting July 1, 2024, the Australian TGA will implement new regulations for GMP inspections of domestic and international manufacturers of medicinal products, APIs, biologicals, and blood products. These new "surveillance inspections" will be shorter, covering all aspects of the pharmaceutical quality system (PQS) but lasting about 50% less time than typical inspections.

GMP certificates issued post-inspection will indicate that a surveillance inspection was conducted. This applies to both domestic and foreign manufacturers who received a "good" or "satisfactory" rating (A1 or A2) in their last TGA inspection. Certain exceptions will prevent the use of shortened inspections.

The goal is to minimize overdue re-inspections in line with manufacturer risk and reduce business disruptions caused by delays.