Transcription of ICH HARMONISED GUIDELINE
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ICH HARMONISED GUIDELINE
INTERNATIONAL CONFERENCE ON HARMONISATION OF TECHNICAL REQUIREMENTS. FOR REGISTRATION OF PHARMACEUTICALS FOR HUMAN USE. ICH HARMONISED GUIDELINE . GUIDELINE FOR elemental impurities . Q3D. Current Step 4 version dated 16 December 2014. This GUIDELINE 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. At Step 4 of the Process the final draft is recommended for adoption to the regulatory bodies of the European Union, Switzerland, Japan, USA and Canada. Q3D. Document History Code History Date Q3D Approval by the Steering Committee under Step 2a. 6 June 2013. Approval by the Steering Committee under Step 2b and 6 June Q3D.
Guideline for Elemental Impurities 2 standards (applicable to drug products) and guidance, and regulatory authority research and assessment reports.
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