ABSTRACT
Stability excursions are unintended lapses in the control parameters (such as temperature, relative humidity, and light) which are designed to preserve a product at experimental, manufacturing, shipping, and patient environment conditions. Significant excursions bring into doubt the validity of data generated in stability studies and the integrity of product during manufacturing and distribution. This document explores how best to reduce the likelihood of stability excursions and how to respond to and analyze the impact of excursions when they occur. Excursion assessment tools and a step by step impact analysis process are included.
