TY - JOUR 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 SP - 118 LP - 126 VL - 59 IS - 2 AU - Richard L. Friedman Y1 - 2005/03/01 UR - http://journal.pda.org/content/59/2/118.abstract N2 - 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. ER -