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.

Read also:

• Guidelines for Stability Testing of Pharmaceutical Products
• Common Interview Questions and Answers on Stability Testing