Total Quality Approach to Sponsor/Contract Laboratory Interface

Good laboratory practice standards (GLPs) were issued with the intended purpose of documenting the quality of laboratory research. These rules have improved laboratory operations and documentation. However, their approach emphasizes inspecting quality as a process rather than for preventing errors in the first place. Total Quality goes beyond GLPs and requires that systems be continually improved to build in quality. This latter approach builds toward elimination of rework that result when GLP inspections uncover unacceptable errors.