Manufacturing standards for overseas manufacturers
This section is for overseas manufacturers of therapeutic goods. You should also see 'Manufacturing basics' which includes information for all manufacturers of therapeutic goods.
According to the Therapeutic Goods Act 1989, the standard of manufacture, and quality control of therapeutic goods manufactured outside Australia, be noted in the registration or listing of those therapeutic goods on the Australian Register of Therapeutic Goods (ARTG), unless the goods are exempt from this requirement by the Act.
- GMP clearance for overseas manufacturers
Good Manufacturing Practice for overseas manufacturers and sponsors, acceptable form of evidence, how to submit evidence
- GMP clearance for prescription medicines
Provides detailed information on how to obtain GMP clearance for overseas manufacturers
Guidelines and standards
- Guidance on licensing/certification inspections
Overseas manufacturers of medicines and other therapeutic goods that are not medical devices, supplied in Australia, must meet an acceptable standard of GMP
- Site master file preparation: PIC/S explanatory notes for pharmaceutical manufacturers
A Site Master File is prepared by a manufacturer and provides information about the production and control of manufacturing operations at a named site, as well as any closely related operations in nearby buildings
- Guidelines for sterility testing of therapeutic goods
Guidance for manufacturers and the TGA, and for referee testing when results are in dispute