RT Journal Article
SR Electronic
T1 Aseptic Processing Contamination Case Studies and the Pharmaceutical Quality System
JF PDA Journal of Pharmaceutical Science and Technology
JO PDA J Pharm Sci Technol
FD Parenteral Drug Association (PDA)
SP 118
OP 126
VO 59
IS 2
A1 Friedman, Richard L.
YR 2005
UL http://journal.pda.org/content/59/2/118.abstract
AB 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.