International scientific guidelines: Guideline on real time release testing (formerly Guideline on parametric release)

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 and analytical procedures and analytical validation

Access this international scientific guideline

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.