96098 Stability6cp; 1hpw (lecture), 2hpw (workshop), on campus
Requisite(s): 96057 GMP for Manufacturing Operations AND 96134 Validation Principles and Practices AND 96059 International GMPs and Quality Assurance AND 96060 Good (Quality Control) Laboratory Practices AND 96069 Contamination Control AND 96062 Good Aseptic Practices and Sterile Products AND 96063 GxP and Quality Auditing Practices AND 96064 Risk Management for Pharmaceutical Operations
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.