A general guide for conducting in-process inspections.

Abstract

Quality-assurance inspections are necessary to assure that studies are conducted according to protocol, standard operating procedures, (SOPs) and government regulations. This article describes observation methods used when conducting inspections, the basic steps of an inspection, and the seven inspection principles (protocol, SOPs, reagents/drugs/test article, equipment, personnel, facility, and management) used to complement and standardize an in-process inspection. In addition, differences among preclinical, clinical, and analytical study inspections are discussed and helpful tips are identified.