What to Do When Accelerated Stability Tests Fail?
Accelerated stability testing simulates extreme conditions to predict product shelf life. But if it fails, then refer below points:
Focus on Long-Term Data:
- If accelerated stability fails but long-term stability passes, use the long-term data for shelf-life determination.
- Real-time data is the gold standard.
Root Cause Analysis:
- Investigate why the product failed under accelerated conditions-temperature sensitivity, packaging, or formulation issues could be the cause.
Regulatory Compliance:
- Shelf life should always be based on real-time stability data (not extrapolated from accelerated testing), in line with WHO guidelines.
Intermediate Data:
- If available, intermediate stability data can be helpful, but avoid extrapolating if accelerated tests fail.
- Real-time stability data is essential for accurate shelf-life claims and product quality assurance.
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