ABSTRACT
In the present-day pharmaceutical industry the Food and Drug Administration (FDA) expects firms to have validated manufacturing processes. Process validation has been defined as a documented program that provides a high degree of assurance that a specific process will consistently produce a product meeting predetermined specifications [1]. For new products or existing products that have recently undergone reformulation, validation is usually an integral part of the process development effort. No such opportunity exists for older established products, however. Of the brands recognized as medical or scientific breakthroughs of the 20th century that continue to be marketed, 21 were introduced before 1980 [2]. This suggests product lines are likely to contain a product for which the manufacturing processes have not been validated, at least not to the extent that is now expected.
