• Quality of Biotechnological Products Q5A - Q5E

    Code Document Title Previously coded
    • Q5BAnalysis of the Expression Construct in Cells Used for Production of r-DNA Derived Protein Products

      Finalised Guideline:
      November 1995

      Q5B
      Description:

      The tripartite harmonised ICH Guideline was finalised under Step 4 in November 1995. It advises on the types of information that are considered valuable in assessing the structure of the expression construct used to produce recombinant DNA derived proteins.

      Implementation:

      Step 5

      EU:

      Adopted by CPMP, December 1995, issued as CPMP/ICH/139/95

      MHLW:

      Adopted January 1998, PMSB/ELD Notification No. 3

      FDA:

      Published in the Federal Register, 23 February 1996, Vol. 61, p. 7006