Domestic Good Manufacturing Practice (GMP) inspections during the COVID-19 pandemic

The Therapeutic Goods Administration (TGA) developed arrangements in April 2020 to allow continued and flexible oversight of Good Manufacturing Practice (GMP) at licensed domestic manufacturing sites during the COVID-19 pandemic.

These arrangements enable inspectors to undertake remote and/or hybrid GMP domestic inspections where suitable, in place of on-site inspections. The TGA will continue to use this process during the COVID-19 pandemic. Routine on-site inspections will recommence at an appropriate time when the pandemic restrictions are lifted.

Use of remote and/or hybrid inspections:

• minimises potential risks where social distancing might be difficult to achieve, inherent in an on-site inspection
• helps ensure continued governance of GMP at licensed domestic manufacturing sites
• facilitates obtaining new GMP licences and/or variations to existing licences
• maintains patient and consumer confidence in therapeutic goods manufactured in Australia by maintaining GMP regulatory oversight.

The new process utilises a risk-based model to evaluate the various options available for inspections on a case-by-case basis, in consultation with relevant staff at each specific manufacturing site.

These options include:

• a remote, virtual inspection with agreed communication tools and desktop review of information
• a hybrid approach including a desktop review and an on-site inspection under agreed, controlled conditions
• an on-site inspection under agreed, controlled conditions where it has been evaluated as necessary and safe to undertake
• deferral of full inspections to a later date under specific conditions only.

The TGA continues to provide essential on-site inspections linked to the Australian Government's COVID-19 response plans and any other potential serious threat to public health, where these sites cannot be assessed remotely.

We expect licensed organisations to maintain GMP compliance and continue to ensure the quality, safety and efficacy of therapeutic goods manufactured at their sites. The TGA will continue supporting industry to focus on service continuity by using alternative approaches to routine regulatory oversight.

For further enquiries, please contact gmp@tga.gov.au.