Canada – Release of ICH Q3C(R8): Impurities: Guideline for Residual Solvents

Health Canada is pleased to announce the implementation of International Council for Harmonisation of Technical Requirements of Pharmaceuticals for Human Use (ICH) Guidance Q3C(R8): Impurities: Guideline for Residual Solvents.

This guidance has been developed by the appropriate ICH Expert Working Group and has been subject to consultation by the regulatory parties, in accordance with the ICH Process. The ICH Assembly has endorsed the final draft and recommended its implementation by membership of ICH.

In implementing this ICH guidance, Health Canada endorses the principles and practices described therein. This document should be read in conjunction with this accompanying notice and with the relevant sections of other applicable Health Canada guidances. This and other Guidance documents are available on the ICH Website. Please note that the ICH website is only available in English. If you would like to request a copy of the French version of the document, please contact the HPFB ICH inbox