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Note for guidance on quality of water for pharmaceutical use

We have adopted this International Scientific Guideline - CPMP/QWP/158/01 Revision, EMEA/CVMP/115/01 Revision 

Last updated

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.
  • All documents and other content published by the European Medicines Agency (EMA) on this website are under the copyright and other intellectual property rights ownership of the EMA. Please refer to Legal notice | European Medicines Agency for further information.

For more information see International scientific guidelines adopted in Australia.

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