Is Good Laboratory Practice Compatible with Total Quality Management?

Abstract

This paper discusses pharmaceutical development pre- and post-good laboratory practice (GLP). GLP, with its overreliance on inspection and the roles of management, the study director, and the quality assurance unit, actually creates a climate which inhibits quality improvements. With the need for continuous improvement to compete in the marketplace, the tendency to regard GLP as a measure of quality hampers pharmaceutical companies. Current GLP regulations are not compatible with total quality management, which calls for designing quality into all processes and involves every member of the team, including the technicians and scientists who perform the day-to-day work. A ttitudes and changes needed to foster quality are discussed.