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ICH Q3D元素杂质指南_2014.12.16_
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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.
翻译:Julia
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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 6 June 2013
consultation.
Q3D Post sign-off corrigendum in: 14 June 2013
Table 4.1 W and A1 were removed from the list of included elemental
impurities in Class 2B and 3 respectively.
Table A2.1
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