A Word About


GMP stands for "Good Manufacturing Practices", which are the general rules under which governments regulate pharmaceutical manufacturing. They include requirements for such things as control of documentation, proper facilities and equipment and training. Over several decades, the pharmaceutical industry and the regulators have added many expectations to the interpretaton of the written GMP rules; the expanded expectatons are called "current Good Manufacturing Practices" or cGMP. It is these fairly detailed and onerous rules that tend to make the production of pharmaceuticals much more expensive than they might otherwise be. The benefit is that we can all have confidence in the quality of those pharmaceuticals.

How does a rule add cost? As an example, in just a few words, the rules call for validation. This has built up over the years into an effort where the typical facility will have thousands of validation documents generated, each consisting of binders of paper.


Page updated 11/25/16


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