ICH Q1A(R2)
The ICH guideline that defines stability testing requirements for new drug substances and products — storage conditions, testing frequency and data needed to support a shelf life.
Why Zone IVb matters in India
India sits in climatic Zone IVb, so long-term conditions are 30 °C ± 2 °C / 75% RH ± 5% rather than the 25 °C / 60% RH used in temperate zones. Submitting Zone II data for an Indian or Gulf market is a predictable deficiency letter.
Pull schedule
Long-term: 0, 3, 6, 9, 12, 18, 24, 36 months. Accelerated (40 °C / 75% RH): 0, 3, 6. Intermediate is triggered if a significant change appears under accelerated conditions.
Related terms
Where this applies
General Injectables
Need help applying this?
Stancor Pharma engineers answer specification questions directly. Contact us.