• Stability Q1A - Q1F

    Code Document Title Previously coded
    • Q1BStability Testing : Photostability Testing of New Drug Substances and Products

      Finalised Guideline:
      November 1996

      Q1B
      Description:

      The tripartite harmonised ICH Guideline was finalised under Step 4 in November 1996. This forms an annex to the main stability Guideline, and gives guidance on the basic testing protocol required to evaluate the light sensitivity and stability of new drugs and products.

      Implementation:

      Step 5

      EU:

      Adopted by CPMP, December 1996, issued as CPMP/ICH/279/95

      MHLW:

      Adopted May 1997, PAB/PCD Notification No. 422

      FDA:

      Published in the Federal Register, 16 May 1997, Vol. 62, No. 95, p. 27115-27122