Division 8. General requirements for human blood - Therapeutic Goods Order No. 88 - Standards for donor selection, testing, and minimising infectious disease transmission via therapeutic goods that are human blood and blood components, human tissues and human cellular therapy products - 8. General requirements for human blood and blood components, human tissues and human cellular therapy products

8. General requirements for human blood and blood components, human tissues and human cellular therapy products

(1) In relation to the collection and manufacture of human blood, blood components, human tissues or human cellular therapy products, a person collecting or manufacturing such products must have procedures in place approved by the TGA that demonstrate:

(a) steps taken to mitigate the risk of infectious disease transmission during collection and manufacture; and

(b) processes for notifying persons/organisations of a donor test result that is positive for, or reactive to, an infectious disease; and

(c) criteria for acceptance and release of human blood and blood components, human tissue and human cellular therapy products based on microbial specifications.

(2) In all cases, procedures in place as required by subsection 8(1) must be followed.

8. General requirements for human blood 8. General requirements for human blood and blood components, human tissues and human cellular therapy products

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8. General requirements for human blood and blood components, human tissues and human cellular therapy products