This guidance is for manufacturers and sponsors of biologicals and human cell or tissue (HCT) products. It specifies requirements around the minimisation of transmission of communicable diseases through the use of therapeutic goods comprising, derived from or containing HCT, as set out in the Therapeutic Goods (Standard for Human Cell and Tissue Products - Donor Screening Requirements) (TGO 108) Order 2021, which came into effect 30 September 2021.
Therapeutic Goods Orders (TGOs) are standards that determine the consistency of product quality, including label quality. As a provider of such therapeutic goods, you must comply with requirements that contribute to their quality and safety, and that mitigate infectious disease risks.
Contents
- About this guidance
- About TGO 108
- Review of TGO 108
- Part 1 - Preliminary
- Section 4 - Definitions
- Section 9 - General requirements
- Subsections 9(1) to 9(3) - Manufacture
- Subsection 9(4) - Blood sample testing timeframe
- Subsection 9(5) - Blood sample testing using IVDs
- Subsection 9(6) - Blood sample testing by laboratories
- Subsections 9(9) and 9(10) - Record keeping
- Section 10 - Medical and social history of donors
- Subsections 10(1) and 10(2) - Donor interviews
- Subsection 10(3) - Deceased donor: medical and social history
- Subsection 10(4) and 10(5) - Donors of HCT materials for plasma fractionation: medical and social history
- Subsection 10(6) - Ocular donors: medical and social history
- Subsection 10(7) - Change in circumstances of donor
- Subsections 10(8) and 10(9) - Screening requirements
- Subsections 10(10) to 10(13) - Vertical transmission risk
- Subsection 10(14) - Directed allogeneic donation
- Section 11 - Blood samples - taking and testing
- Subsections 11(1) to 11(4) - Living donor blood sampling
- Subsection 11(5) - Blood sampling for plasma fractionation
- Subsection 11(6) - Deceased donor blood sampling
- Subsections 11(7) to 11(10) - Living and deceased donor infectious disease testing
- Subsection 11(11) - Infectious disease testing for plasma fractionation
- Subsections 11(12) and 11(13) - Infectious disease testing for donors less than 18 months old
- Subsection 11(14) - Infectious disease testing for donors who have consumed breast milk
- Subsections 11(15) to 11(17) - Assessment of testing results
- Subsections 11(18) to 11(19) - Archiving of serum of plasma of blood samples
- Section 12 - Physical assessment
- Subsection 12(1) - Potential donor testing for infectious diseases
- Subsection 11(2) - Donor physical assessments
- Schedule 1 - Ineligibility criteria for donor selection
- Items 1 to 5 - Known infection or potential exposure to certain viruses
- Item 6 - Injected with drugs for a non-medical reason
- Item 7 - Recipients of viable, non-human cells or tissues
- Item 8 - At risk of prion disease
- Item 9 - Recipients of human pituitary derived hormone
- Item 10 - At risk of acquiring a blood borne infection
- Item 11 - Allogeneic products
- Item 12 - At increased risk due to sexual practices
- Item 13 - Prison inmate for 72 or more consecutive hours
- Item 14 - Active infection, fever or infectious disease
- Item 15 - Travel to specific regions
- Items 16 to 18 - Risk of malaria
- Item 19 - Undiagnosed febrile illness consistent with malaria
- Item 20 - Active infection
- Items 21 and 22 - Deceased donors
- Items 23 to 26 - Risk of transmission of vaccination strain
- Annex 1: Location of requirements in dossier
- Version history
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