GMP surveillance inspections and extended validity of TGA GMP certificates

From 1 July 2024, we are introducing temporary new arrangements for GMP inspections of domestic and overseas manufacturers of medicines, Active Pharmaceutical Ingredients (APIs), biologicals and blood products. These inspections will be called ‘surveillance inspections.’

What are surveillance inspections?

Surveillance inspections are full-scope, reduced-duration re-inspections of manufacturers. This means that the inspection will cover all aspects of the manufacturers’ Pharmaceutical Quality System (PQS) and operations; however, the inspection duration can be reduced by approximately 50% of the typical inspection time.

For example, if the typical inspection duration is 4 days, under a surveillance inspection the duration can be reduced to 2 days. 

Surveillance inspections may be conducted on-site, remotely or as a hybrid inspection, and will only be used once for each eligible manufacturing site. 

GMP certificates issued by us following a surveillance inspection will clearly state that a surveillance inspection was used.

We anticipate surveillance inspections will be in place for a period up to two years.

Who is eligible for a surveillance inspection?

Domestic and overseas manufacturers that demonstrated a good or satisfactory compliance rating (A1 or A2) at their previous TGA inspection may be eligible for a surveillance inspection.

Manufacturers meeting the below criteria will not be eligible for surveillance inspections:

• sites that were rated as A3 or Unacceptable at the last inspection
• those with ongoing compliance signals or concerns
• sites requiring initial licencing inspections
• sites requiring inspections for a variation to their licence.

Manufacturers and Sponsors do not need to apply for a surveillance inspection to be conducted, as we will determine the eligibility of a manufacturer as part of our inspection planning processes. If your site is selected for a surveillance inspection, we will provide written notification via the inspection announcement letter.

Why are surveillance inspections being introduced?

During the COVID-19 pandemic and related travel restrictions we maintained our GMP inspection program through the introduction of ‘remote inspections’. While these arrangements provided continued GMP oversight of manufacturers, the initial delay in implementation, and added complexity of remote inspections has contributed to a backlog of GMP inspections.

We are now taking additional actions to maintain our risk-based re-inspection frequencies and ensure we meet the needs of the regulated industry.

Surveillance inspections aim to:

• Enable us to maintain regulatory oversight of existing authorised manufacturers and continue to monitor manufacturer compliance with the Manufacturing principles while;
• Reducing the number of overdue re-inspections to a level commensurate with manufacturer risk and reduce business disruption caused by delays to re-inspections.

Extended validity of TGA issued domestic GMP certificates

TGA licensed sites that have not had a re-inspection in the last three years may still apply for domestic GMP or MRA certificates. The TGA will issue GMP certificates with an extended expiry from 3 years to 4 years for licensed sites that have not had a re-inspection in the last three years.  

For further enquiries, please contact GMP@health.gov.au.