• Q1A - Q1F Stability

    Code Document Title Previously coded
    • Finalised Guideline:
      February 2003

      Description :

      This Guideline has been revised a second time and has reached Step 4 of the ICH process in February 2003.

      This Guideline provides recommendations on stability testing protocols including temperature, humidity and trial duration for climatic Zone I and II. Furthermore, the revised document takes into account the requirements for stability testing in Climatic Zones III and IV in order to minimise the different storage conditions for submission of a global dossier.

      Implementation :

      Step 5

      EU :

      Adopted by CPMP, March 2003, issued as CPMP/ICH/2736/99

      MHLW :

      Adopted 3 June 2003, PFSB/ELD Notification No. 0603001

      FDA :

      Published in the Federal Register, 21 November 2003, Vol. 68, No. 225, p. 65717-18