Aseptic processing contamination case studies and the pharmaceutical quality system.

PDA J Pharm Sci Technol

Food & Drug Administration, Center for Drug Evaluation & Research, Division of Manufacturing & Product Quality, USA.

Published: July 2006

This paper summarizes parenteral drug contamination case studies presented at industry conferences and a Food and Drug Administration advisory committee meeting in the period of 2000-2004. CGMP deficiencies associated with each contamination event are discussed. The key role of a well-functioning quality system in contamination prevention is emphasized.

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