9General requirements

9 General requirements

(1) An HCT product must be manufactured in accordance with procedures that mitigate the risk of infectious disease transmission. (2) An HCT product must not be released for supply, unless the applicable screening procedures and requirements specified in this instrument are satisfied. (3) Acceptance criteria based on microbial specifications must be applied to HCT materials used in the manufacture of an HCT product. General requirements relating to testing of blood samples (4) Blood samples of a donor of HCT materials must be tested: (a) as soon as practicable after the blood sample is taken; or (b) in accordance with the timeframe specified by the manufacturer of the IVD medical device or the in-house IVD medical device that is used for testing the sample; or (c) where testing is conducted outside of Australia—within a timeframe that is validated by the testing laboratory. (5) Blood samples must be tested using IVD medical devices or in-house IVD medical devices that: (a) use the most appropriate methodology available that is validated for testing the samples (including cadaveric samples); and (b) where testing is conducted in Australia—are either included in the Register or exempt from the requirement to be included in the Register, or are the subject of an approval or authority under the Act; and (c) where testing is conducted outside of Australia—are: (i) approved by a relevant regulatory authority in the country in which the testing is conducted; and (ii) used in a facility that has been approved for such testing by a relevant regulatory authority in the country in which the testing is conducted; and (iii) considered acceptable by the Therapeutic Goods Administration. (6) Where the testing of a blood sample is conducted by a laboratory that is not under the direct control of the manufacturer of the relevant HCT product: (a) the testing must be conducted under a contract between the manufacturer and the laboratory; and (b) the contract mentioned in paragraph (a) must clearly set out the responsibilities of the manufacturer and the laboratory, and include arrangements to ensure that information relating to matters in this section and any other relevant details relating to the IVD medical devices or in‑house IVD medical devices used for such testing can be obtained from the laboratory. (7) The testing of blood samples must take into account all factors that may cause plasma dilution. (8) Where plasma dilution is suspected at a level sufficient to alter the test results in relation to a blood sample, and a pre-infusion sample is unavailable for testing, then: (a) an algorithm must be applied to assess the extent of plasma dilution; and (b) the extent of plasma dilution must be less than 50 per cent, unless use of samples with more than 50 per cent plasma dilution is validated by the manufacturer of the IVD medical devices or in-house IVD medical devices used for testing the sample. (9) Records must be maintained in relation to the following: (a) the tests performed in relation to blood samples and the results of those tests; and (b) the IVD medical device or in-house IVD medical device used for testing the samples; and (c) any test modifications; and (d) any evaluations of, or anomalies in, test results. (10) Procedures must be implemented for notifying a donor of HCT materials, a relevant health practitioner, a relevant hospital and any other relevant organisation, of a test result in relation to the donor that is indicative of a disease or carrier state.