PT  - JOURNAL ARTICLE
AU  - Anthony M. Cundell
TI  - Microbial Identification Strategies in the Pharmaceutical Industry
DP  - 2006 Mar 01
TA  - PDA Journal of Pharmaceutical Science and Technology
PG  - 111--123
VI  - 60
IP  - 2
4099  - http://journal.pda.org/content/60/2/111.short
4100  - http://journal.pda.org/content/60/2/111.full
SO  - PDA J Pharm Sci Technol2006 Mar 01; 60
AB  - A commonly discussed question amongst pharmaceutical microbiologists, and the quality assurance organizations they serve, is what microbial isolates from the many microbial monitoring programs at a manufacturing facility need to be characterized, identified to genus, identified to species, or strain-typed? This article discusses the overall strategies that may be successfully applied to microbial identification in support of microbial monitoring of utilities, pharmaceutical ingredients, the manufacturing environment, and finished products. Emphasis in the article is given to the justification of the microbial identification program, selection of identification methods, and use of speciation in successful product failure investigations.