October 03, 2021: Pharmaceutical Interview Questions and Answers

#SpecifiedOrganismsAndSource #InterpretSpecificationLimitForMicrobiologyTest

1. When test for specified organisms found positive, what it indicates for each organism?

Name of specified organismSourceRisk
Escherichia coli  Gut floraThe organism indicates fecal contamination
SalmonellaeGut floraFecal contamination with high pathogenicity
S. aureusHuman skin human skin and nose, detectable in feces.High pathogenicity potential. risk to product quality due to resistance to preservatives
P. aeruginosaWater inhabitant mainly stored waterHigh pathogenicity potential
ClostridiaFound where anaerobic conditions are prevalentpathogenicity potential
C. albicansCandida 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

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