My definition of “specification” is rather simple: It’s a promise.

Just like any other promise, you’d better be sincere when you make it and be able to keep it. Failure to keep a promise brings disappointment. Frequent failure leads to distrust. And consciously breaking a promise is nothing less than deceitful.

Just as in our personal lives, the pharmaceutical industry makes a promise to its health care professionals and patients every time it establishes a product specification.

Whether it is a raw material or component from a supplier, in-process material, or final product, a specification is the industry’s promise to provide a product that possesses the attributes known to make it work.

Anything outside of the specification range is either unknown, because it has not been studied, or known to have some probability of a negative effect. Neither is acceptable.

The same could be said for process control ranges. Although they are applied to the manufacturing process and facilities, they nonetheless are “promises” based on a scientific field of study with respect to product quality.

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