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 Q3D Approval by the Steering Committee under Step 2b and release for public consultation. 6 June 2013 Q3D Post sign-off corrigendum in: Table W and Al were removed from the list of included elemental impurities in Class 2B and 3 respectively.
GUIDELINE FOR ELEMENTAL IMPURITIES ICH Harmonised Guideline Having reached Step 4 of the ICH Process at the ICH Steering Committee meeting on 12 November 2014, this guideline is recommended for adoption to the regulatory parties to ICH. TABLE OF CONTENTS
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