• Q2 Analytical Validation

    Code Document Title Previously coded
    • Finalised Guidelines:
      October 1994/November 1996

      Description :

      The tripartite harmonised ICH Guideline on Text (previously coded Q2A) was finalised under Step 4 in October 1994. This identifies the validation parameters needed for a variety of analytical methods. It also discusses the characteristics that must be considered during the validation of the analytical procedures which are included as part of registration applications.

      The tripartite harmonised ICH Guideline on Methodology (previously coded Q2B) was finalised under Step 4 in November 1996. It extends the Guideline Q2A to include the actual experimental data required, along with the statistical interpretation, for the validation of analytical procedures.

      The Guideline on Methodology has been incorporated into the Guideline on Text in November 2005 and then renamed Q2(R1), without any changes in the contents of the two Guidelines.

      Guideline on Text Implementation :

      Step 5

      EC :

      Adopted by CPMP, November 1994, issued as CPMP/ICH/381/95

      MHLW/PMDA :

      Adopted July 1995, PAB/PCD Notification No. 755

      FDA :

      Published in the Federal Register, 1 March 1995, Vol. 60, p. 11260

      Health Canada :

      Implemented 5 June 2015, #: 15-106599-601

      Swissmedic :

      Please refer to the press release on Swissmedic’s website for information on implementation

      Validation of Analytical Procedures: Methodology

      Implementation :

      Step 5

      EU :

      Adopted by CPMP, December 1996, issued as CPMP/ICH281/95

      MHLW :

      Adopted October 1997, PMSB/ELD Notification No. 338

      FDA :

      Published in the Federal Register, 19 May 1997, Vol. 62, No. 96, p. 27463-7

      Swissmedic :

      Swissmedic is referring input to the EU