TGA introduces shorter Surveillance Inspections
Recommendation
25-27 June 2025
Register now for ECA's GMP Newsletter
From 1 July 2024, the Australian TGA will introduce, at least temporarily, new regulations for GMP inspections of domestic and foreign manufacturers of medicinal products, active pharmaceutical ingredients (APIs), biological products and blood products, so-called surveillance inspections.
These are repeat inspections of manufacturers with a shorter duration, but according to the TGA with full scope. This means that the inspection should cover all aspects of the pharmaceutical quality system (PQS) and the operations, but be reduced by around 50 % of the usual inspection time.
The GMP certificates issued after the inspection will then state that a surveillance inspection has been carried out.
Who is eligible for this?
Both domestic and foreign manufacturers who received a "good" or "satisfactory" rating (A1 or A2) in their last TGA inspection. However, there are also clearly defined exceptions where shortened inspections are not possible.
Objectives
The primary aim is to reduce overdue re-inspections to a level commensurate with the manufacturer's risk and to reduce business disruption caused by delays in re-inspections.
Related GMP News
16.06.2025FDA Warning Letter with Supplier Qualification Observations
11.06.2025Root Cause Investigations criticised at EU Company
21.05.2025More FDA Warning Letters citing Quality Oversight
21.05.2025New Version of GMP Auditors Handbook available
21.05.2025FDA: more unannounced Inspections also outside the US