• Q5A - Q5E Quality of Biotechnological Products

    Code Document Title Previously coded
    • Q5D Derivation and Characterisation of Cell Substrates Used for Production of Biotechnological/Biological Products

      Finalised Guideline:
      July 1997

      Q5D
      Description :

      The tripartite harmonised ICH Guideline was finalised under Step 4 in July 1997. This document provides broad guidance on appropriate standards for the derivation of human and animal cell lines and microbes used to prepare biotechnological/biological products and for the preparation and characterisation of cell banks to be used for production.

      Implementation :

      Step 5

      :

      EC, Europe - Adopted by CPMP, September 1997, issued as CPMP/ICH/294/95

      :

      MHLW/PMDA, Japan - Adopted 14 July 2000, PMSB/ELD Notification No. 873

      :

      FDA, US - Published in the Federal Register, 21 September 1998, Vol. 63, No. 182, p. 50244-9

      :

      Health Canada, Canada - Implemented 5 January 2001, Catalogue No. H42-2/67-21-2000E

      :

      Swissmedic, Switzerland - Refer to the press release on Swissmedic, Switzerland's website