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 It was automatically repealed (sunset) on 1 October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.
Posted by Dr. Tim Sandle, Pharmaceutical Microbiology
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Pharmaceutical Microbiology