How is stability data evaluated?

Stability data must be thoroughly and accurately documented to be evaluated by regulatory agencies such as the FDA. It is critical that pharmaceutical manufacturers have data to back up their research findings in the event of an FDA inspection. One of the primary pieces of data to be evaluated is documentation that ensures that the required conditions were held consistently for the entire length of the study. If a failure occurs during the study, the incident must also be documented to be reported to the FDA. The process of compiling mapping data for the chamber and documenting that stabilization protocols have been followed at each step is known as validation. Read more about stability protocols and validation requirements here.

Stability study data is recorded through the stability chamber’s monitoring system software. The monitoring system provides real-time data on chamber performance for temperature and humidity, C02 levels, uniformity and any deviations from prescribed set points. This data is typically accessible through a cloud-based or physical company server and will notify study conductors of any changes in chamber conditions.

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