October 03, 2021: Pharmaceutical Interview Questions and Answers
1. When test for specified organisms found positive, what it indicates for each organism?
|Name of specified organism||Source||Risk|
|Escherichia coli||Gut flora||The organism indicates fecal contamination|
|Salmonellae||Gut flora||Fecal contamination with high pathogenicity|
|S. aureus||Human skin human skin and nose, detectable in feces.||High pathogenicity potential. risk to product quality due to resistance to preservatives|
|P. aeruginosa||Water inhabitant mainly stored water||High pathogenicity potential|
|Clostridia||Found where anaerobic conditions are prevalent||pathogenicity potential|
|C. albicans||Candida albicans is an opportunistic pathogenic yeast that is a common member of the human gut flora.||Potential pathogens for specific situations E.g. vaginal preparations.|
2. How to interpret specification limit for microbiology test results for bio burden testing?
Pharmacopeia allows variability in test results equal to a factor of two. E.g. if the specified microbial limit is 10, the maximum accepted microbial count is 20 CFU and still meets the product specification.
● 10 microorganisms: maximum acceptable count = 20
● 100 microorganisms: maximum acceptable count = 200
● 1000 microorganisms: maximum acceptable count = 2000