You can consider alternative options as long as they do not impede prompt recall and access to data required for compliance to regulatory requirements and responsibilities.
You can only contract out release for supply to an independent authorised person if the authorised person holds or works under a TGA licence or a current GMP clearance that includes release for supply.
Sponsors wanting to conduct RFS
Release for supply is a manufacturing step that requires a TGA licence. If a sponsor wants to perform release for supply they must:
hold a TGA manufacturing licence
be authorised within the marketing authorisation for that step in manufacture
meet the responsibilities of a release for supply manufacturer
The Department of Health and Aged Care acknowledges First Nations peoples as the Traditional Owners of Country throughout Australia, and their continuing connection to land, sea and community. We pay our respects to them and their cultures, and to all Elders both past and present.