ICH Stability Zones and Stability Testing Requirements for Drug Products

ICH has defined the requirements on stability testing in its guideline Q1A. In this video we have discussed
1. Why stability testing is required
2. Different stabt zones based on mean kinetic temperature.
3. Temperature and humidity of different stability zones
4. General consideration for stability testing of drug products
5. Stability conditions, minimum data required for submission, stability time points, etc.
6. Accelerated stability conditions, intermediate stability conditions and long term stability conditions for general case
7. Stability requirements for refrigerated products
8. Stability conditions for products packed in semi permeable containers
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#accelerated stability
#intermediate stability
#longterm stability