Australia – Microbiological quality of medicinal cannabis products

Complying with Therapeutic Goods (Microbiological Standards for Medicines) (TGO 100) Order 2018

This guidance will assist sponsors and manufacturers of medicinal cannabis products to comply with Therapeutic Goods (Microbiological Standards for Medicines) (TGO 100) Order 2018, referred to in this guidance as TGO 100.

What is TGO 100?

TGO 100 specifies the minimum microbiological quality requirements (including preservative efficacy requirements) that a medicine should comply with throughout its shelf life, unless it is exempt.