ABSTRACT
The biopharmaceutical industries are self-regulated. It is the role of the FDA to assure that self-regulation is conducted through: the development and promulgation of guidelines and regulations, the review of research and new product applications, and the spot checking of facility design, function, and management. Those spot checks-the scheduled and unscheduled regulatory visits and inspections-are often a source of
some trauma. However, a regulatory investigation in a real sense is the equivalent of the dream of every student: an exam for which you know the questions in advance, for which you are allowed and encouraged to make your own interpretation of those questions, and for which you are permitted and encouraged to use previously written documents as the answer “crib notes.” In the case of a good laboratory practices (GLP) inspection, controlling the process is a simple combination of a few self-regulation principles and the application of a GLP checklist.
