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.
Continue at: https://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Quality/Q10/Step4/Q10_Guideline.pdf
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