Abstract
Monitoring of microbiological quality in the pharmaceutical industry is an important criterion that is required to justify safe product release to the drug market. Good manufacturing practice (GMP) and efficient control on bioburden level of product components are critical parameters that influence microbiological cleanliness of medicinal products. However, since microbial dispersion through the samples follows Poisson distribution, the rate of detection of microbiologically defective samples lambda (λ) decreases when the number of defective units per batch decreases. When integrating dose-response model of infection (Pinf) of a specific objectionable microbe with contamination module, the overall probability of infection from a single batch of pharmaceutical product can be estimated. The combination of Pinf with detectability chance of the test (Pdet) will yield a value that could be used as a quantitative measure of the possibility of passing contaminated batch units of product with a certain load of a specific pathogen and infecting the final consumer without being detected in the firm. The simulation study can be used to assess the risk of contamination and infection from objectionable microorganisms for sterile and non-sterile products.
- GMP
- Poisson distribution
- dose-response model of infection
- microbiological quality
- simulation study
- uncertainty factor
- Received July 2, 2016.
- Accepted October 24, 2016.
- Copyright © 2016, Parenteral Drug Association
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