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

Description

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:

  • collection
  • processing
  • testing
  • storage
  • release for supply
  • quality assurance of human blood and blood components, human tissues and human cellular therapy products.

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

Please consult the Contact Officer for more information and to ascertain the level of compliance (if any) that may be required.

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

Therapeutic Goods Administration

Contact details

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

Please use these contact details for help or more information:

Clinical Trials, Medicines Regulation Division

Therapeutic Goods Administration

Department of Health

Operating address: 136 Narrabundah Lane
Symonston, Australian Capital Territory 2609
Toll Free: 1800 020 653
Phone: 02 6232 8106
Fax: 02 6232 8112
Email: clinical.trials@tga.gov.au

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

Please use these contact details for help or more information:

Enquiries

Therapeutic Goods Administration

Department of Health

Operating address: 136 Narrabundah Lane
Symonston, Australian Capital Territory 2609
Mailing address: PO BOX 100
Woden, Australian Capital Territory 2606
Toll Free: 1800 020 653
Email: info@tga.gov.au
Website: Therapeutic Goods Administration (Opens in new window)