Aseptic processing contamination case studies and the pharmaceutical quality system.
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.
Friedman
Richard L
RL
Food & Drug Administration, Center for Drug Evaluation & Research, Division of Manufacturing & Product Quality, USA.
D001207:Asepsis / Q000379:methods* / Q000592:standards; D004340:Drug Contamination / Q000517:prevention & control*; D004345:Drug Industry / Q000295:instrumentation / Q000379:methods / Q000592:standards; D004866:Equipment Contamination / Q000517:prevention & control; D006801:Humans; D011786:Quality Control