Saturday, 12 January 2019

Microbiological Standards for Medicines


Australia - Therapeutic Goods Order No.77 Microbiological standards for medicines (TGO 77) has been in force since 2010. It was automatically repealed (sunset) on 1 October 2018 in accordance with the Legislative Instruments Act 2003. A new instrument, Microbiological Standards for Medicines 2018 TGO 98 succeeded TGO 77 on this date to provide continuing clarity on the requirements for microbiological quality of medicines.


TGO 98 reflects the current requirements of TGO 77 without regulatory change. It specifies the minimum microbiological requirements with which a medicine must comply throughout its shelf life, i.e. which medicines must comply with a Test for Sterility and Bacterial Endotoxin testing; which medicines must comply with a preservative efficacy test; and the acceptance criteria for microbiological quality that apply to nonsterile medicines.

TGO 98 and its Explanatory Statement are registered on the Federal Register of Legislation.

See: https://www.tga.gov.au/tgo-98-microbiological-standards-medicines-2018

Posted by Dr. Tim Sandle, Pharmaceutical Microbiology

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