TGA News Issue 42 (November 2003) - Blood & tissues
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 Red Cross Blood Service
On 12 September 2003, the TGA confirmed that restrictive conditions had been placed on the manufacturing licence held by the South Australian Australian Red Cross Blood Service (ARCBS).
An unscheduled audit of Adelaide Blood Bank facilities found a number of breaches of the Good Manufacturing Practice Licence held by the Blood Bank.
On 19 September 2003, the TGA announced that it had completed audits of all the major ARCBS sites that undertake manual testing and manual entry of data and found a general degree of adequate training, processes and procedures in place.
- Blood banks get qualified all-clear from TGA (19 September 2003) <http://www.tga.gov.au/media/2003/030919bloodb.htm>
- Blood regulator takes action on South Australian Blood Service (12 September 2003) <http://www.tga.gov.au/media/2003/030912sablood.htm>
Facility registration
Following consultations, the TGA is seeking the assistance of organisations and individuals in identifying activities involving human cells, tissues and biological therapies for therapeutic application. A Facility Registration Form and Guide have been designed to allow the identification of organisations and individuals that are involved in activities utilising human tissues and cells. The Guidance section of the form gives examples of activities that are of interest to the TGA, and also lists a number of activities that are not intended to be covered under the registration process.