The Therapeutic Goods Administration (TGA) Australia has published a new guidance on Therapeutic Goods Orders (TGO) 109 to provide a detailed explanation on the general and specific requirements for standards of biologics in November 2021.
The guidance can be used as a reference for manufacturers and sponsors of biologicals and provides further information on the general manufacturing and quality requirements for therapeutic products that have links to human cells or tissues (HCT). More information can be found in the Therapeutic Goods (Standards for Biologicals – General and Specific Requirements) (TGO 109) Order 2021.
In general, the guidance covers a few topics which include standards for all biologicals, standard for human musculoskeletal tissue products, standard for human cardiovascular tissue products and others.
The TGOs need to be adhered to and as a HCT product provider, there are requirements that need to be met to maintain the quality and safety of HCT products, which will also prevent risks of infectious diseases.
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