New temporary TGA arrangements: Introduction of surveillance inspections and extended validity of GMP Certificates 

Following discussion during the TGA-Industry Working Group on GMP (TIWGG) meetings, which are attended by CMA, the TGA has notified CMA of new temporary arrangements being introduced for the ongoing regulation of domestic and overseas manufacturers that will be implemented from 1 July 2024

  

Surveillance inspections 

The TGA has developed a new risk-based approach to address the backlog of GMP inspections developed during the COVID-19 pandemic called ’surveillance inspections’. These inspections will be a full-scope, reduced-duration inspection enabling the TGA to maintain regulatory oversight of a greater number of existing authorised manufacturers with existing TGA existing resources. As the duration of these inspections will be reduced, commensurately the fees for the inspection will also reduce. 

Surveillance inspections will only be utilised once per manufacturing site and will apply to re-inspections of manufacturers with a history of compliance with GMP. They will not be applied to inspections of new manufacturers or those with a history of poor compliance. The TGA has provided that they may use surveillance inspections for the conduct of on-site, remote and hybrid inspections. 

TGA GMP certificates and inspection reports will clearly articulate the inspection was conducted as a surveillance inspection. Successful completion of surveillance inspection will result in the issue of valid GMP certificate of compliance. Manufacturers and Sponsors do not need to apply for a surveillance inspection as the TGA will determine the eligibility of a manufacturer as part of their inspection planning. 

Extended validity of GMP Certificates 

Manufacturers and sponsors are advised that the expiry of GMP certificates for TGA licensed sites has been extended to 4 years. 

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