This section is for manufacturers of biological products. You should also see 'Manufacturing basics' which includes information for manufacturers of all types of therapeutic goods.

Codes of practice

• Australian code of good manufacturing practice for human blood and blood components, human tissues and human cellular therapy products
  Applies to blood, human tissues and human cellular therapy products manufacturers that undertake the collection, processing, testing, storage, release for supply, and quality assurance of human blood and blood components, human tissues and human cellular therapy products

Guidelines and standards

• Australian regulatory guidelines for biologicals (ARGB)
  Information for manufacturers, sponsors, health professionals and the general public on the legal arrangements in Australia for the supply and use of human cell and tissue-based therapeutic goods (collectively defined as 'biologicals')
• Guidance on licensing/certification inspections
  The TGA performs inspections of Australian manufacturers of therapeutic goods to ensure that they meet an acceptable standard of GMP or comply with QMS standards