The RAPS store will be under maintenance Saturday, 17 April between 5 AM and 12 PM EST. Store functionality may be unavailable at times during this window.
We apologize for any inconvenience caused during this time.

Regulatory Focus™ > News Articles > Australia Planning Updated GMPs for Blood and Tissue Products

Australia Planning Updated GMPs for Blood and Tissue Products

Posted 11 September 2012 | By Alexander Gaffney, RAC 

Australia's Therapeutic Goods Administration (TGA) is beginning the process of revising its code of good manufacturing practices (GMPs) for the manufacture of blood and tissue products, the agency announced on 11 September.

The revisions will eventually update TGA's August 2000 code, GMPs for Blood and Tissues, and will involve a 12-month implementation period once finalized.

TGA said it anticipates making two primary revisions to the code: a revised portion dealing specifically with human blood, blood components, human tissues and human cellular therapy products and another portion establishing new standards for donor selection, testing and disease minimization.

Until the new code is released, sponsors should continue to comply with the existing regulations found in the August 2000 version of GMPs for Blood and Tissues and Appendix 4 of the Australian Regulatory Guidelines for Biologicals, explained TGA.


Read more:

TGA - Revising the Code of GMP for blood and tissues

 

© 2021 Regulatory Affairs Professionals Society.

Regulatory Focus newsletters

All the biggest regulatory news and happenings.

Subscribe