INTERNATIONAL CO UNCIL FOR HARMONISATION OF TECHNICAL
REQUIREMENTS FOR PHARMACEUTICALS FOR HUMAN USE
ICH HARMONISED GUIDELINE
V ALIDATION OF A NALYTICAL P ROCEDURES
Q2 (R2)
Draft version
Endorsed on 24 March 2022
Currently under public consultatio n
At Step 2 of the ICH Process, a consensus draft text or guideline, agreed by the
appropriate ICH Expert Working Group, is transmitted by the ICH Assembly to the
regulatory authorities of the ICH regions for internal and external consultat ion,
according to national or regional procedures.
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