Chapter 19. Good Laboratory Practice in the Research and Development Laboratory

Summary

Good Manufacturing Practice covers control of production and quality including the development of standard operating procedures, sampling, testing, documentation and release procedures. Testing is conducted according to Good Laboratory Practice. Compliance with both sets of guidelines requires monitoring by independent quality assurance staff. This is an expensive procedure but at least the basic tenets should be incorporated into academic research and development laboratories. The overall responsibility for compliance with the principles of GLP rests with the designated management. Traceability of all reagents and materials is necessary and work should proceed according to a written, though flexible, study plan with written protocols for individual procedures. The study director should oversee the work and prepare the final report. Quality assurance should be performed by someone with specific responsibility for that function not a member of the research team.