International scientific guideline: ICH topic Q 7 - Note for guidance on good manufacturing practice guide for active pharmaceutical ingredients

About this guideline

Overseas effective date: 29 May 2002

Categories: Quality | Manufacturing

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TGA annotations

This guideline has been adopted as a Manufacturing principle in Australia. Sponsors should refer to the Determination and the associated notation located on the Manufacturing pages of the TGA website.

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.