These guidelines are for manufacturers and the Official Analyst of the Therapeutic Goods Administration (TGA) Laboratories, and as guidance for referee testing when results are in dispute.
The guidelines have been updated to reflect the changes made to the British Pharmacopoeia sterility test method.
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GuidanceHow the TGA assesses the safety of materials derived from human and other animal species, naturally susceptible to TSE, that are used in the manufacture of therapeutic goods.
Supporting documents
TGA guidelines for sterility testing of therapeutic goods
[Word, 3.6 MB]
TGA guidelines for sterility testing of therapeutic goods
[PDF, 334.07 KB]
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