International scientific guideline: Questions and answers on implementation of risk-based prevention of cross-contamination in production and ‘Guideline on setting health-based exposure limits for use in risk identification in the manufacture of different

About this guideline

Adopted by the TGA: 08 June 2023

Overseas effective date: 19 April 2018

Categories: Shared facilities | risk identification | exposure limits | toxicological data | residual active substances | PDE

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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.