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Therapeutic Goods (Microbiological Standards for Medicines) (TGO 100) Order 2018
9Sterility and Bacterial Endotoxin testing
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9 Sterility and Bacterial Endotoxin testing
Where: (a) a medicine is required to be sterile or to comply with a bacterial endotoxin test by an individual or general monograph of a default standard; or (b) a medicine through its labelling or packaging states or implies that the medicine is sterile, the medicine must comply with the Test for Sterility and, if applicable, the Bacterial Endotoxin Test, of a default standard.