The Therapeutic Goods Administration (TGA) has developed new arrangements to allow continued and flexible oversight of Good Manufacturing Practice (GMP) at licenced domestic manufacturing sites during the COVID-19 pandemic.
The TGA has developed a process to enable inspectors to undertake remote and/or hybrid GMP domestic inspections where suitable, in place of on-site inspections. The TGA will only use this process during the COVID-19 pandemic. Routine on-site inspections will recommence at an appropriate time when the pandemic restrictions are lifted.
These new arrangements will:
- minimise potential impacts from an on-site inspection on industry staff and department personnel by reducing the need for or duration of on-site inspections of domestic manufacturing sites where social distancing might be difficult to achieve
- help ensure continued governance of GMP at licenced domestic manufacturing sites
- facilitate new GMP licences and/or variations to existing licences
- maintain patient and consumer confidence in therapeutic goods manufactured in Australia by maintaining GMP regulatory oversight.
This process will utilise 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 will continue 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 licenced 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.
