TGA: New GMP Inspection Arrangements

The Australian TGA has introduced temporary 'surveillance inspections' for domestic and overseas manufacturers of medicines, Active Pharmaceutical Ingredients (APIs), biologicals, and blood products.

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