Guideline on control of impurities of pharmacopoeial substances: compliance with the European Pharmacopoeia general monograph "Substances for pharmaceutical use" and general chapter "Control of impurities in substances for pharmaceutical use"

We have adopted this International Scientific Guideline - CPMP/QWP/1529/04.

Last updated

3 June 2024

About this guideline

Overseas effective date: April 2004

Categories: Quality | Impurities

TGA annotations: Nil

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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