PT  - JOURNAL ARTICLE
AU  - Richard L. Friedman
TI  - Aseptic Processing Contamination Case Studies and the Pharmaceutical Quality System
DP  - 2005 Mar 01
TA  - PDA Journal of Pharmaceutical Science and Technology
PG  - 118--126
VI  - 59
IP  - 2
4099  - http://journal.pda.org/content/59/2/118.short
4100  - http://journal.pda.org/content/59/2/118.full
SO  - PDA J Pharm Sci Technol2005 Mar 01; 59
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.