ABSTRACT
This chapter describes the principles of study of stability for regulatory filings in the European Union (EU), Japan, and the United States. Details provided here comprise the core stability data package for new drug substances and products and not for abbreviated or abridged applications, variations, or clinical trial applications. 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 retest period for the drug substance or a shelf life for the drug product and recommended storage conditions. The choice of test conditions is based on an analysis of the effects of climatic conditions, which are described on the basis of the mean kinetic temperature derived from climatic data; thus, the world can be divided into four climatic zones, I-IV.
