VALIDATION OF ANALYTICAL PROCEDURES: METHODOLOGY

仪器资料 · 发表于 2018-5-2 15:17:56

VALIDATION OF ANALYTICAL PROCEDURES: METHODOLOGY
INTERNATIONAL CONFERENCE ON HARMONISATION OF TECHNICAL
REQUIREMENTS FOR REGISTRATION OF PHARMACEUTICALS FOR HUMAN USE
ICH HARMONISED TRIPARTITE GUIDELINE
VALIDATION OF ANALYTICAL PROCEDURES: METHODOLOGY
Recommended for Adoption
at Step 4 of the ICH Process
on 6 November 1996
by the ICH Steering Committee
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, Japan and USA.

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