Procedures Used for Sterility Testing of Parenteral Drugs by an FDA Field Laboratory

Abstract

The development and use of effectwe sterility tests should be an essential part of the quality control program of any industry engaged in production and marketing of parenteral drugs. This presentation briefly outlines the sterility testing procedures employed by a typical field laboratory of the Food and Drug Administration (FDA) with particular emphasis on the control measures employed to ensure the validity of these tests. Problems which can be encountered with some of the techniques involved, particularly membrane filtration, are presented. A mutual understanding of the procedures employed by industry and FDA may provide both with a better insight into providing consumers with safer and effective drugs.