Audit of medicine manufacturers

To obtain a licence to manufacture therapeutic goods in Australia, a manufacturer must demonstrate compliance with manufacturing principles including Codes of Good Manufacturing Practice (GMP).

Further details on audits are available <http://www.tga.gov.au/docs/html/auditmed.htm> including frequency and scheduling, duration, the audit team, appeals and complaints and an example of a typical TGA audit of a medicine manufacturer.

Australian manufacturers licensed to manufacture therapeutic goods

The document Australian manufacturers licensed to manufacture therapeutic goods has recently been updated. It lists Australian manufacturers that are licensed to manufacture therapeutic goods as at 5 May 2003. It now includes a new section detailing licence suspensions.