Photostability testing of pharmaceutical products

Abstract

In recent years, regulatory authorities and industry associations have worked toward international harmonization of regulatory guidance. The U.S. Food and Drug Administration (PDA) has often met with industry and other regulatory representatives to seek concurrence on suitable technical procedures for pharmaceutical development that are scientifically based and harmonized. This article discusses the perspective of the U.S. (PhRMA and PDA) EWG members concerning photostability and, in particular, on the scope of a recent ICH document in relation to light sources and exposure levels. © 1998 The United States Pharmacopeial Convention, Inc. All Rights Reserved.