Australian TGA and manufacturing processes

As part of the Department of Health, the TGA safeguards and enhances the health of the Australian community through effective and timely regulation of therapeutic goods. If you are manufacturing goods into the Australian market you will need to meet TGA Standards

• What the TGA regulates
  The TGA is responsible for regulating the supply, import, export, manufacturing and advertising of therapeutic goods
  
  
• How the TGA regulates
  The TGA regulates therapeutic goods through: pre-market assessment, post-market monitoring and enforcement of standards, licensing of Australian manufacturers and verifying overseas manufacturers' compliance with the same standards as their Australian counterparts
  
  
• Responsibilities of manufacturers of medicines and biologicals
  Manufacturers of medicines, APIs, biologicals, blood and blood components and haematopoietic progenitor cells have responsibilities: during manufacture, informing the TGA, licence-specific responsibilities and GMP inspections.

Visit  https://www.tga.gov.au/