20141216ICHQ3D元素杂质指南..docVIP

INTERNATIONAL CONFERENCE ON HARMONISATION OF TECHNICAL REQUIREMENTS FOR REGISTRATION OF PHARMACEUTICALS FOR HUMAN USE ICH HARMONISED GUIDELINE GUIDELINE FOR ELEMENTAL IMPURITIES 元素杂质指南 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 4.1 W and A1 were removed from the list of included elemental impurities in Class 2B and 3 respectively. ???Table A2.1 the Class for Ni was changed to read 3 instead of 2 14 June 2013 Q3D Post sign-off minor editorial corrections including: removal of references to Appendix 5 (pgs i13); deletion of redundant text (pg4); change of Option 2 to Option 2a(pg10); insertion of text under Safety Limiting Toxicity (pg35); reference to “metals” in text and “metal” in Table A4.7 title with “elementals” and “elements” (pg 73); and deletion of header Table A4.10 (pg75). 26 July 2013 Q3D Addition of line numbers to facilitate the provision of comments by stakeholders. 30 September 2013 Q3D Approval by the Steering Committee under Step 4 and recommendation for adoption to the ICH regulatory bodies. 12 November 2014 ? Current Step 4 Version Code History Date Q3D Corrigendum to correct: the modifying factor in the text of the safety assessment for Selenium (changed to 2 instead of 10 consistent with Section 3.1); and two references for consistency in the safety assessments for Barium (deleted reference ) and Vanadium (reviewed reference). 16 December 2014 ? Legal notice