Australia Planning Updated GMPs for Blood and Tissue Products
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.
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