Trending Stability Data

Stability storage and testing

Pharmaceutical regulators have made it clear that the same investigation approach should be adopted for out-of-trend (OOT) results as for out-of-specification (OOS) results. However, regulators offer little guidance on identifying OOT data. For OOT results to be identified promptly during stability studies, data must be continuously trended in some way. The problem is that trends are often not obvious during the early phases of a stability study.

This webinar offers some practical approaches for the continuous trending of stability data and covers:

  • Regulatory expectations for OOT results
  • When is a result OOT?
  • Identifying OOT results
    • Regression control chart
    • By-time-point method
    • Slope control chart method