• Q5A - Q5E Quality of Biotechnological Products

    Code Document Title Previously coded
    • Finalised Guideline:
      September 1999

      Description :

      The tripartite harmonised ICH Guideline was finalised  under Step 4 in March 1997. This is concerned with testing and evaluation of the viral safety of biotechnology products derived from characterised cell lines of human or animal origin. The purpose is to provide a general framework for virus testing experiments for the evaluation of virus clearance and the design of viral tests and clearance evaluation studies.

      (Please note that a typographic error has been corrected on 23 September 1999 on Table A-1. the Genome of the Reovirus 3 is RNA (and not DNA as previously printed). The correction was integrated in the Guideline that was then renamed Q5A(R1)).

      Implementation :

      Step 5


      EC, EuropeAdopted by CPMP, April 1997, issued as CPMP/ICH/295/95


      MHLW/PMDA, Japan Adopted, 22 February 2000, PMSB/ELD Notification No. 329


      FDA, United States Published in the Federal Register, 24 September 1998, Vol. 63, No. 185, p. 51074


      Health Canada, Canada Implemented 5 January 2001, Catalogue No. E H42-2/67-18-2000E


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