This guidance is for manufacturers and sponsors of biologicals. It specifies the general manufacturing and quality requirements for therapeutic goods comprising, derived from or containing human cells or tissues (HCT) set out in the Therapeutic Goods (Standards for Biologicals-General and Specific Requirements) (TGO 109) Order 2021 and provides an interpretation of how the various requirements can be met.
Generally, Therapeutic Goods Orders (TGOs) are standards that determine the consistency of product quality, including label quality. As an HCT product provider, you must comply with requirements that contribute to the quality and safety of HCT products, and that mitigate infectious disease risks.
Contents
- About this guidance
- About TGO 109
- Review of TGO 109
- Guidance on the requirements of TGO 109
- Part 2 - Standard for all biologicals
- Section 8 - What this Part is about
- Section 9 - Diseases and conditions that may compromise biologicals
- Section 10 - Critical materials
- Section 11 - Microbial contamination control strategy
- Section 12 - Samples for bioburden testing
- Section 13 - Bioburden testing requirements
- Section 14 - Sterilisation
- Section 15 - Collection from deceased donors
- Section 16 - Storage and transportation: HCT materials
- Section 16 - Storage and transportation: biologicals
- Section 17 - Containers of biologicals
- Part 3 - Standard for human musculoskeletal tissue products
- Section 18 - What this Part is about
- Section 19 - Application of this Part
- Section 20 - Collection from deceased donors
- Section 21 - Bioburden testing
- Section 22 - Demineralised products
- Section 23 - Freeze-dried products
- Section 24 - Storage and transportation
- Part 4 - Standard for human cardiovascular tissue products
- Section 25 - What this Part is about
- Section 26 - Application of this Part
- Section 27 - Tissue not subjected to a bioburden reduction process
- Section 28 - Tissue subjected to a bioburden reduction process
- Section 29 - Heart valves
- Section 30 - Storage and transportation
- Part 5 - Standard for human ocular tissue products
- Section 31 - What this Part is about
- Section 32 - Application of this Part
- Section 33 - Collection
- Section 34 - Storage and transportation
- Section 35 - Excised cornea - testing of storage medium etc.
- Section 36 - Containers
- Section 37 - Examination and evaluation
- Part 6 - Standard for human skin products
- Section 38 - What this Part is about
- Section 39 - Application of this Part
- Section 40 - Processing etc.
- Section 41 - Bioburden testing
- Section 42 - Freeze-dried skin allografts
- Section 43 - Storage and transport
- Part 7 - Standard for human amnion products
- Section 44 - What this Part is about
- Section 45 - Application of this Part
- Section 46 - Collection
- Section 47 - Terminal sterilisation
- Section 48 - Dehydrated or freeze-dried products
- Section 49 - Storage and transportation
- Annex 1: Location of requirements in dossier
- Version history
Supporting documents
Topics