ABSTRACT
The primary expectation of the Food and Drug Administration (FDA) is that for pharmaceutical manufacturing processes, including finished drugs and active pharmaceutical ingredients (APIs) for both human and animal use, any critical cleaning process must be validated. Critical cleaning processes are those that involve surfaces that, if cleaned inadequately, have a reasonable probability of contarninating the subsequently manufactured product. For the most part, this involves product contact surfaces, surfaces that the subsequently manufactured product actually contacts, allowing for the possibility of direct transfer of the residues from the surface to that product. Other nonproduct-contact surfaces may also be considered critical, provided there is evidence (or a reasonable scientific judgment) that residues on those surfaces may transfer to the manufactured product. For nonproduct-contact surfaces, the issue of validation has to be decided on the specifics of the
situation. The definition of critical cleaning processes is not explicitly stated in the FDA cleaning validation guidance document. However, it is one that appears to be assumed and is consistent with the requirement in the guidance document on process validation that focuses on manufacturing processes [l ,2].
