This is the third in a series of seven articles discussing the Recall Root Cause Research
project conducted by the Division of Manufacturing and Product Quality, Center for Drug …

A total of 236 samples of infant foods, including honey, dry cereal, nonfat dry milk, evaporated
milk, canned formula, and canned baby food, were collected in the New York City area …

Pharmaceutical drug products often contain antimicrobial agents as a preservative in their
formulation. These excipients are required to destroy or impede the growth of microorganisms …

Part one of this three-part series examined the scientific basis for recombinant methods and
the history and extensive studies utilized previously for the acceptance of alternate tests in …

Pharmaceutical manufacturing generally comprises a complex, multi-step processing system
in which significant risks from microbial contamination are presented by diverse sources …

Prior to testing for the presence of bacterial endotoxin, parenteral products are handled and
stored in a variety of ways. Two incidents, detected by the US Food and Drug Administration, …

… botulinum toxin, type E. Recently, we have been evaluating the system for its abilityto
detect other types, particularly in foods. Initially, the sensitivity of the capillary diffusion system …

Any parenteral therapy theoretically carries a risk of bacterial endotoxins contamination
which can result in a number of physiological responses in humans, including fever. It is …

In response to regulatory citations for not including plant isolates in method suitability and
growth promotion testing of microbiological culture media, the authors make the case that the …

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. …