III. CGMP Legal Principles

          What is CGMP?

Notebook:

First, the law is asserting that the quality necessary to market the drug to the public is built into the product as the drugs are manufactured under CGMP. CGMPs are simply a set of rules that amount to being organized and careful--building the quality in as you go, as opposed to establishing quality by testing.

In a testing approach to establish manufacturing product quality, you must depend on some kind of measurement of selected attributes. Another problem with the testing approach is that only small samples of the products are tested and the results of those tests are extrapolated to the untested units. However, the connection may not be valid.

The fact is that production is a very dynamic process--people change, machines wear down, deliveries come in that may or may not be what you ordered. This dynamic system poses some unknowns. The law is asserting that the manufacturer is the responsible agent since good manufacturing avoids adulteration of products. The manufacturer must implement good practices.

Also as briefly discussed above in Section 2, deemed adulterated is legal terminology which holds that proving adulteration does not carry with it an obligation to show that the product has some measurable or detectable defect (i.e., contains specks, packaged incorrectly, etc.). Under the law, if a company simply does not follow or meet those requirements of CGMP, they are in violation and their products can be charged as adulterated.

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