Australian Therapeutic Goods Administration (TGA) published on Sep 2023 updated Information for sponsors and manufacturers on “Nitrosamine Impurities in Medicines”
- TGA Actions
- Sponsor and manufacturer responsibilities
- Background to investigations of nitrosamines in medicines
- Origin of nitrosamine impurities
- Investigating potential for nitrosamine impurities
- Acceptable intake nitrosamine limits
- Testing for nitrosamine impurities
- Informing the TGA of nitrosamine impurities and associated actions
- Further information
- Useful resources
- Related links