Putting Stability Under a Microscope – 6 Key Components


Stability plays a significant role in the life of a drug product. A drug must remain potent and safe long after it leaves a manufacturing facility. According to the ICH Q1A guideline, “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.”

This paper defines stability testing, discusses the recent increase in oversight by regulators, and establishes the six key components that reflect best practices of a robust stability testing program.