The identification of live organisms in a controlled environment is a regulatory requirement as set forth in several FDA documents.1, 2, 3 The CFR speaks generically of “environmental conditions” that may have an “adverse effect on product quality.” Such conditions include bacteria and fungi as are found in the air or on surfaces. It is the purpose of this paper to present current information as to FDA, ISO, and USP guidance and to provide a basic primer on microbial identification.
Authors: Herbert N. Prince, Ph.D., Daniel L. Prince, Ph.D.
