ABSTRACT
This chapter provides a regulations, Scale-Up and Postapproval Changes (SUPAC) guidances, and future trends and Food and Drug Administration (FDA) initiatives from a stability requirement perspective. The FDA recognizes that the pharmaceutical industry often needs to make postapproval changes in manufacturing for a variety of reasons. The SUPAC guidances are based on the principle that the extent of impact along with the probability of impact of a given change or changes on the product quality determines the quantity of stability information required. The FDA is generally available to provide guidance in special situations and should be consulted. Since stability requirements are continuously evolving, the reader is encouraged to consult the latest FDA guidances in order to design and execute an acceptable postapproval change stability program. The stability requirement, amount, and duration for the above changes will depend on the probability and potential degree of impact of the change on drug product quality.
