There are course requisites for this subject. See access conditions.
This is an advanced subject in the Master of Good Manufacturing Practice (GMP), addressing the key requirements for managing a successful stability trial program. Students review the relevant International Conference on Harmonisation (ICH) guidance documents, and the practical application of the key requirements for stability. Students develop specific skills in planning and evaluating new and ongoing stability trials.
The focus is on the compliance and practical aspects of stability studies for active pharmaceutical ingredients and pharmaceutical products defined by the ICH Q1 series of guidance documents.
Detailed subject description.