TGA licensed manufacturer: what it means (and why 'TGA approved' is the wrong term)
What it means when a manufacturer is TGA licensed, why people search for 'TGA approved' or 'TGA certified' manufacturers, and what to ask a manufacturer to show you.
Brands often search for a “TGA approved” or “TGA certified” manufacturer. The accurate term is TGA licensed: Australian manufacturers of medicines hold a manufacturing licence issued by the Therapeutic Goods Administration (TGA).
What the licence covers
A manufacturing licence covers a specific site and the manufacturing steps it is licensed to carry out, such as blending, filling, packing, testing and release. The TGA inspects licensed sites against its Good Manufacturing Practice (GMP) requirements.
Why the wording matters
“Approved” and “certified” are loose terms. “Licensed” tells you there is a TGA manufacturing licence covering that site. Ask any manufacturer which licence they hold and what it covers.
What to ask a manufacturer
Do you hold a TGA manufacturing licence for this site?
Does it cover my dosage form and the steps I need?
Will I receive batch records and release documentation?
DB Pharmaceuticals
DB Pharmaceuticals holds a TGA GMP manufacturing licence for its Kings Park facility in Sydney. See our quality approach.
This guide is general information only. It is not regulatory or legal advice, and requirements change. Check current requirements with the TGA or a qualified regulatory consultant before making decisions about your product.