What are surveillance inspections?

Surveillance inspections are comprehensive but shorter re-inspections of manufacturers, covering all aspects of their Pharmaceutical Quality System (PQS) and operations. These inspections will last about half the usual duration. They can be conducted on-site, remotely, or as a hybrid, and will be used only once per eligible site. GMP certificates will note if a surveillance inspection was used. These inspections will be in place for up to two years.

Who is eligible?

Manufacturers with a good or satisfactory compliance rating (A1 or A2) from their previous TGA inspection may qualify. The following are not eligible:

• Sites rated A3 or Unacceptable at the last inspection
• Sites with ongoing compliance issues
• Sites needing initial licencing inspections
• Sites needing inspections for a licence variation

Manufacturers do not need to apply; eligibility will be determined during TGA's inspection planning.

Why introduce surveillance inspections?

The COVID-19 pandemic caused delays and complexities in GMP inspections, creating a backlog. Surveillance inspections will help maintain regulatory oversight, manage the backlog, and minimize business disruption.

Extended Validity of TGA GMP Certificates

TGA licensed sites without a re-inspection in the last three years may apply for GMP or MRA certificates. The TGA will extend the expiry of these certificates from 3 years to 4 years.

Source:

TGA: Notices