Preparing for an FDA preapproval inspection.

During the past several years, the U.S. Food and Drug Administration (FDA) has increased its compliance and enforcement activities in relation to the approval of new pharmaceutical products. FDA has published Compliance Program Guidance Manual 7346.832, "preapproval inspections/investigations," which describes the manner in which FDA will manage this program, as well as describing expectations concerning laboratory and production controls for the development and manufacturing of a new product. This program, and the dialogue that it has stimulated between the agency and the pharmaceutical industry, has helped define contemporary criteria for assessing the validity of scientific and technical data supporting marketing applications. The program focuses on a comparison of the proposed commercial manufacturing process vis-a-vis the methods and controls used to produce supplies utilized in pivotal clinical and bioequivalence studies. This article presents an industry perspective regarding preparation for an FDA preapproval inspection (PAI) for two categories of products: those which were under development before the expectations of the PAI program were fully elucidated and those which are entering the development pipeline today.