Critical regulatory requirements for a stability program

Abstract

This chapter addresses the principles of stability studies in the drug development process. It gives an overview of different types of stability studies that support the entire drug development phases. It also discusses the purpose that one wants to achieve with the data set that these studies generate. This chapter also discusses stability issues within the framework of the FDA cGMP guidelines as expressed in 21CFR Part 211. This review of cGMP regulations that tie to the stability program as well as to the testing laboratory is essential for pharmaceutical analysts to understand the process. This applies to all phases of stability studies including set up, testing, data review, and follow up on out-of-specification results. Details of FDA and ICH regulations are found in Chapter 3 - Understanding ICH Guidelines Applicable to Stability Testing. Other details on how to manage a stability program are addressed in subsequent chapters of this book.