Australian Code of Good Manufacturing Practice for Human Blood and Blood Components, Human Tissues and Human Cellular Therapy Products - Australian Government


You must comply with this Code if you intend to manufacture therapeutic goods which consist of biological components such as blood, human tissues and / or human cells.

This Code establishes the standards for the quality assurance of human blood and blood components, human tissues and human cellular therapy products regarding:

  • collection
  • processing
  • testing
  • storage
  • release for supply.

Manufacturers of specified products are required to hold a therapeutic goods manufacturers licence.

Service type

Code of Practice

A code of practice is a set of rules which details how people in a certain industry should behave. A code of practice can be defined as a result of legislation or by industry regulators and bodies.

Act(s) name

Therapeutic Goods Act 1989 Australian Government

Regulation(s) name

Therapeutic Goods Regulations 1990 Australian Government

Administering agency

Department of Health and Aged Care

Therapeutic Goods Administration

Contact details

Contact Email, Phone and Address Details for this service in simple two column table format, header then data.