Guideline on real time release testing (formerly Guideline on parametric release)

We have adopted this International Scientific Guideline - EMA/CHMP/QWP/811210/2009-Rev1

Last updated

8 January 2025

About this guideline

Overseas effective date: 1 October 2012

Replaces: CPMP/QWP/3015/99. Note for Guidance on Parametric Release (adopted by TGA 22 May 2002)

Categories: Quality | Specifications, analytical procedures and analytical validation

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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