The government is now operating in accordance with the Guidance on Caretaker Conventions, pending the outcome of the 2025 federal election.
Note-for-guidance-on-quality-of-water-for-pharmaceutical-use
[PDF, 136.64 KB]
About this guideline
Overseas effective date: 1 June 2002
Categories: Quality | Excipients
TGA annotations:
In conformity with the Note for Guidance on Good Manufacturing Practice for Active Pharmaceutical Ingredients - CPMP/ICH/4106/00 (which is adopted by the TGA effective from 29 May 2002), the TGA recommends that for the purposes of compliance with this guideline on water quality, potable water should comply with the latest WHO guidelines for drinking water quality.
- Where EU guidelines adopted in Australia include references to EU legislation (including EC Directives and Regulations), the requirements contained in the referenced EU legislation are not applicable to the evaluation of medicines by the TGA.
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For more information see International scientific guidelines adopted in Australia.