ABSTRACT
A preapproval inspection (PAI) is a visit by one or more food and drug inves-tigators to review the adequacy and accuracy of the information provided in a regulatory submission [The FDA Compliance Program Guidance Manual on Pre-Approval Inspections/Investigations (Program 7346.832)]. The program was a direct result of the generic drug scandal of the late 1980s. Prior to this time, the Food and Drug Administration (FDA) relied on firms to provide accurate data in support of their submissions. Prior to the implementation of the PAI program, companies essentially operated on an honor system with the FDA. This honor system was effectively terminated with the generic drug scandal. In fact, in 1990 Dr. David Kessler, then commissioner of the FDA, was quoted as saying, “What I learned most from the generic drug scandal is that in the end, the data this agency acts on has to be audited. The honor system is out the window” [1]. As a result, the objectives of the PAI were to:
Ensure that facilities listed in the new drug applications (NDA) have the capabilities to fulfill the commitments to manufacture, process, control, package, and label a drug product following good manufac-turing practices (cGMPs).
