Quality of biotechnological products: stability testing of biotechnological/biological products

We have adopted this International Scientific Guideline - 3AB5
Previous titles/other references: ICH Q5C, CPMP/ICH/138/95

About this guideline

Overseas effective date: July 1996

Categories: Biological medicines | Drug substance | Stability (drug substance)

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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