TGA News Issue 42 (November 2003) - Manufacturing
Note: The information in this issue of TGA News may no longer be current. Please check with the TGA before relying on the information on these web pages.
Australian Codes of GMP
This website includes a list of current manufacturing standards (as at August 2003) <http://www.tga.gov.au/docs/html/gmpcodes.htm>, specified in the Therapeutic Goods Act 1989 as Manufacturing Principles, for different categories of therapeutic goods (except for medical devices) as regulated by the TGA.
The Questions and Answers on the Australian Code of Good Manufacturing Practice for Medicinal Products <http://www.tga.gov.au/docs/html/gmpcodqa.htm> have been updated.
Standard of Overseas Manufacturers
The Guidelines on Standard of Overseas Manufacturers has been updated and the Overseas Manufacturer GMP Clearance Application Form has also been revised to reflect the current requirements.