This post concerns the introduction of temporary new arrangements by the TGA, for GMP inspections of:
- domestic and overseas manufacturers of medicines
- Active Pharmaceutical Ingredients (APIs)
- biologicals and blood products.
When were the temporary new arrangements for GMP inspections introduced and what are they called?
The temporary new arrangements for GMP inspections were introduced on 1 July 2024 and these inspections are called ‘surveillance inspections.’
What are surveillance inspections?
Essentially they are 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 e.g. if the typical inspection duration is 4 days, under a surveillance inspection the duration can be reduced to 2 days.
Why are surveillance inspections being introduced and what is their aim?
During the COVID-19 pandemic and related travel restrictions, the TGA maintained its 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.
The TGA is now taking additional actions to maintain its risk-based re-inspection frequencies in order to ensure that it meets the needs of the regulated industry.
Surveillance inspections aim to:
- Enable the TGA 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.
Where may surveillance inspections be conducted?
Surveillance inspections may be conducted on-site, remotely or as a hybrid inspection, and will only be used once for each eligible manufacturing site.
How long is it anticipated that surveillance inspections will be in place
The TGA anticipates that surveillance inspections will be in place for a period up to two years.
Which manufacturers are eligible for a surveillance inspection?
Domestic and overseas manufacturers who demonstrated a good or satisfactory compliance rating (A1 or A2) on their previous TGA inspection may be eligible for a surveillance inspection.
Which manufacturers will not 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.
Does a manufacturer have to apply for a surveillance inspection?
No, Manufacturers and Sponsors do not need to apply for a surveillance inspection to be conducted, except for TGA licensed sites that have not had a re-inspection in the last three years, which may still apply for domestic GMP or MRA certificates.
The TGA will determine the eligibility of a manufacturer as part of its inspection planning processes. If your site is selected for a surveillance inspection, the TGA will provide written notification via the inspection announcement letter.
How will surveillance inspections be identified?
GMP certificates issued by the TGA following a surveillance inspection will clearly state that a surveillance inspection was conducted.
Extended validity of TGA issued domestic certificates
The expiry of existing GMP certificates for TGA licensed sites has been extended from 3 to 4 years.
Source: TGA