Understanding ICH guidelines applicable to stability testing

Abstract

This chapter discusses International Conference of Harmonization (ICH) guidelines that are related to the Stability Sciences. It gives a brief history of how the Q1A was initiated. A summary of Q1A(R2) discusses thoroughly the current regulations that the industry supports and practices. While this handbook was being prepared, the FDA Stability Guidance was withdrawn; therefore, a brief discussion of the guidance status has been included. A discussion of mean kinetic temperature is included for a basis of understanding stability testing conditions.