TGA Licensed Manufacturer of Therapeutic Goods
In Australia, the Therapeutic Goods Act 1989 requires, with certain exceptions, that manufacturers of therapeutic goods hold a license.
In relation to therapeutic goods that are not medical devices, the Therapeutic Goods Act defines 'manufacture' as:
1. to produce the goods; or
2. to engage in any part of the process of producing the goods or of bringing the goods to their final state, including engaging in the processing, assembling, packaging, labelling, storage, sterilising, testing or releasing for supply of the goods or of any component or ingredient of the goods as part of that process.
To obtain a license to manufacture therapeutic goods, a manufacturer must demonstrate, during a factory audit by the Therapeutic Goods Administration (TGA), compliance with manufacturing principles which include relevant Codes of GMP and Quality Systems.