Therapeutic Goods (Standards for Biologicals—General and Specific Requirements) (TGO 109) Order 2021 (Cth)

Therapeutic Goods (Standards for Biologicals—General and Specific Requirements) (TGO 109) Order 2021

I, John Skerritt, as delegate of the Minister for Health and Aged Care, make the following order.

Dated 24 September 2021

Adjunct Professor John Skerritt Deputy Secretary Health Products Regulation Group Department of Health

Contents Part 1—Preliminary 1 Name 2 Commencement 3 Authority 4 Definitions 5 Standards 6 Application 7 Transitional arrangements Part 2—Standard for all biologicals 8 What this Part is about 9 Diseases and conditions that may compromise biologicals 10 Critical materials 11 Microbial contamination control strategy 12 Samples for bioburden testing 13 Bioburden testing requirements 14 Sterilisation 15 Collection from deceased donors 16 Storage and transportation 17 Containers of biologicals Part 3—Standard for human musculoskeletal tissue products 18 What this Part is about 19 Application of this Part 20 Collection from deceased donors 21 Bioburden testing 22 Demineralised products 23 Freeze‑dried products 24 Storage and transportation Part 4—Standard for human cardiovascular tissue products 25 What this Part is about 26 Application of this Part 27 Tissue not subjected to a bioburden reduction process 28 Tissue subjected to a bioburden reduction process 29 Heart valves 30 Storage and transportation Part 5—Standard for human ocular tissue products 31 What this Part is about 32 Application of this Part 33 Collection 34 Storage and transportation 35 Excised cornea—testing of storage medium etc. 36 Containers 37 Examination and evaluation Part 6—Standard for human skin products 38 What this Part is about 39 Application of this Part 40 Processing etc. 41 Bioburden testing 42 Freeze‑dried products 43 Storage and transportation Part 7—Standard for human amnion products 44 What this Part is about 45 Application of this Part 46 Collection etc. 47 Terminal sterilisation 48 Dehydrated or freeze‑dried products 49 Storage and transportation