13.12.2021

What is the purpose of stability testing?

The purpose of stability testing is to provide evidence on how the quality of a drug substance or drug product varies with time under the influence of a variety of environmental factors such as temperature, humidity, and light, and to establish a re-test period for the drug substance or a shelf life for the drug product and recommended storage conditions.

[GMP Compliance Adviser, Chapter 14.E.1]