Professional Documents
Culture Documents
Rutendo Kuwana
Technical Officer
Prequalification of Medicines Program
WHO
(Source Handbook of stability testing and pharmaceutical development regulations, methodologies, and best practices)
Long term:
Year 1: every 3 months
Year 2: every 6 months
Subsequent years: annually
Accelerated:
Minimum three points including t0 and tfinal, e.g. 0, 3, 6.
Intermediate:
Four points including t0 and tfinal, e.g. 0, 6, 9, 12.
Freezer (-20°C 5°C) Can range from 5°C ± 3°C or 25°C ± 2°C or 30°C ± 2°C