Document ID: chunk:federal_register_of_legislation:F2021L01332:reg:10
Version: federal_register_of_legislation:F2021L01332
Segment Type: reg
Provision Reference: reg 10
Character Range: 13666–15064

10  Critical materials
 (1) The critical materials used in the manufacture of a biological must:
 (a) not be contaminated with, or be likely to introduce, microorganisms or other infectious disease agents; and
 (b) not adversely affect the quality, safety or efficacy of the biological; and
 (c) where the critical materials are solutions that come into contact with HCT materials or biologicals (other than critical materials mentioned in paragraph (d))—be manufactured under an approved quality management system and either:
 (i) be supplied as a sterile solution; or
 (ii) satisfy sterility requirements specified in an applicable standard; and
 (d) where the critical materials are non-sterile antimicrobial agents used in a bioburden reduction process for HCT materials—be passed through a 0.22µm filter prior to use in the bioburden reduction process; and
 (e) where the critical materials are of human or animal origin (other than HCT materials)—meet the requirements set out in:
 (i) the TGA Approach to TSE; and
 (ii) the Guidance on Virus Validation Studies.

     Critical materials not included in the Register
 (2) The following information in relation to critical materials that are not included in the Register must be available and documented:
 (a) screening tests performed and quality control specifications, including criteria and limits for tests; and
 (b) storage conditions.