International scientific guideline: Note for guidance on quality of water for pharmaceutical use

About this guideline

Overseas effective date: 30 Oct 2022

Categories: Quality | Excipients

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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 29th 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.

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For more information see International scientific guidelines adopted in Australia.

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.