storage conditions
- Guideline or reference source
- ICHQ1A Stability testing of new drug substances and drug products
- Definition
- The acceptable variations in temperature and relative humidity of storage facilities for formal stability studies. The equipment should be capable of controlling the storage condition within the ranges defined in this guideline. The actual temperature and humidity (when controlled) should be monitored during stability storage. Short term spikes due to opening of doors of the storage facility are accepted as unavoidable. The effect of excursions due to equipment failure should be addressed, and reported if judged to affect stability results. Excursions that exceed the defined tolerances for more than 24 hours should be described in the study report and their effect assessed.
- Narrower Term
- special precautions for storage
- Related Term
- accelerated testing
- climatic zones
- expiry date
- shelf life
- storage statement drug substance
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