ICH Q5B Guideline: Quality of Biotechnological Products: Analysis of Expression Construct (Q5B)
Channel: DR Technical Gyan
Date: 2020-06-02

ICH Q5B Guideline: Quality of Biotechnological Products: Analysis of Expression Construct (Q5B).
ICH Guideline - Quality of Biotechnological Products: Analysis of Expression Construct of the cells production in used for r-DNA derived protein products (Q5B)
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
Current Step 4 version dated 30 November 1995.