University of Technology, Sydney

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96098 Stability

6cp
There are course requisites for this subject. See access conditions.

Description

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.

Access conditions

Note: The requisite information presented in this subject description covers only academic requisites. Full details of all enforced rules, covering both academic and admission requisites, are available at access conditions and My Student Admin.