ICH guideline Q4B Annex 8 on evaluation and recommendation of pharmacopoeial texts for use in the ICH regions sterility test - general chapter

We have adopted this International Scientific Guideline – ICH Q4B Annex 8; EMA/CHMP/ICH/645592/2008

Last updated

11 December 2024

About this guideline

Overseas effective date: December 2009

Categories: ICH | Quality

Quality | Specifications and 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.
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.

Product types

Topics