Procedures used for sterility testing of parenteral drugs by an FDA field laboratory
Guilfoyle, D.E.; Yager, J.F.
Journal of Parenteral Science and Technology a Publication of the Parenteral Drug Association 38(4): 138-141
1984
ISSN/ISBN: 0279-7976 PMID: 6491856 Document Number: 230289
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.