Chapter 2: Safe, unsafe and improper manufacturing practices
Many of the world’s medicines are manufactured in precisely the sort of stainless steel and glass factories that are the showpieces of modern industry, fitted out with sophisticated equipment and staffed by white-coated experts. Procedures for Good Manufacturing Practice (GMP) are laid down in fine detail, with approval and inspection by the health authorities, and laboratories are to hand for checking every stage of production. In almost every respect, the standards applicable to drug manufacturing are accessible, absolute and applicable across the board. In the making of pharmaceuticals, just as in the building of aircraft, there is after all no room for error: the misplacement of a single screw when constructing a plane may lead to the death of hundreds of passengers; with medicines, which can be active in microgram quantities, the toxic dose of the active substance may be only very slightly higher than the dose used in treatment, and the slightest slip in formulation may have tragic consequences for numerous users. In one respect the pharmaceutical situation creates even more stringent demands; while an aircraft will be checked and rechecked by any conscientious operator before each flight, a medicine, once packaged in the factory, is unlikely to be examined again before it is opened and consumed by the patient; at that stage even a serious quality defect is likely to go unrecognized until disaster supervenes.
You are not authenticated to view the full text of this chapter or article.