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

About this guideline

Overseas effective date: 12 December 2017

Categories: Quality | Specifications and analytical procedures and analytical validation

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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.