"Which is more appropriate: inclusion in compendial testing of a firm's own in-house isolates with "wild-type" characteristics that are specific to that firm's site, or inclusion of organisms isolated many decades ago from a North Carolina blueberry (
Aspergillus brasiliensis [
niger] ATCC 16404) or from an outer ear infection (
Pseudomonas aeruginosa ATCC 9027)...?"
"The Role of In-House Microbial Isolates in Contamination Control"
Director of Quality and Operations
Parenteral Drug Association, June 2013