13. Requirements in relation to critical materials used in collection and manufacture
(1) In relation to manufacturing procedures relating to human blood and blood components, human tissues and human cellular therapy products, critical materials used in those manufacturing procedures must be selected and evaluated to ensure that they are not contaminated with or likely to introduce bacteria or other infectious agents.
(2) In relation to critical materials used in the manufacture of human blood and blood components, human tissues and human cellular therapy products , the following requirements apply:
(a) in the case of critical materials that are solutions, which contact the human cells or tissue during collection, processing, storage or transport (other than the antimicrobial agents used in a cell or tissue cleaning process validated by the sponsor or manufacturer) such solutions must be:
(i) manufactured under an approved quality management system and supplied as a sterile solution; or
(ii) tested for and found to satisfy sterility requirements in accordance with a test for sterility specified in a current default standard or Therapeutic Goods Order made under section 10 of the Act which applies to that specific product.
(b) in the case of critical materials that are antimicrobial agents used in a cell or tissue cleaning process validated by the sponsor or manufacturer that are not supplied sterile, such materials should be passed through a 0.22µm filter prior to use in the manufacture of human blood or blood components, human tissues or human cellular therapy products;
(c) in the case of critical materials containing any components of human or animal origin (other than the starting materials of blood, cells or tissue) such materials must have been sourced, tested (if methodology is available) and assessed as presenting a minimal risk of transmitting infectious disease agents in accordance with the requirements set out in the following documents:
(i) TGA approach to minimising the risk of exposure to Transmissible Spongiform Encephalopathies (TSEs) through therapeutic goods, published by the TGA at < http://www.tga.gov.au/industry/tse-approach.htm >; and
(ii) the EMEA guidance document titled Note for Guidance on Virus Validation Studies: The design, contribution and interpretation of studies validating the inactivation and removal of viruses Feb 1996, published by the EMEA at <http://www.emea.europa.eu/pdfs/human/bwp/026895en.pdf>;
(d) in the case of critical materials that are not required to be in the Register, or that are the subject of an approval or authorisation in relation to the requirement to be included in the Register, the following information must be documented:
(i) screening tests performed; and
(ii) QC specifications, e.g. criteria and limits for the tests performed; and
(iii) storage conditions; or
(e) if the information specified in (d)(i) to (iii) is not available from the sponsor or manufacturer of the material, the material must be assessed by the manufacturer of the human blood or blood component, human tissue or human cellular therapy product.