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Article CommentaryCommentary

Quantitative Microbial Risk Assessment of Pharmaceutical Products

Mostafa Essam Eissa
PDA Journal of Pharmaceutical Science and Technology May 2017, 71 (3) 245-251; DOI: https://doi.org/10.5731/pdajpst.2016.007047
Mostafa Essam Eissa
HIKMA Pharma for Pharmaceutical Industry, 2nd Industrial Zone, 1st Plot, 6th of October City, Giza, Egypt, P.O. 13311
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  • For correspondence: mostafaessameissa@yahoo.com
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In This Issue

PDA Journal of Pharmaceutical Science and Technology: 71 (3)
PDA Journal of Pharmaceutical Science and Technology
Vol. 71, Issue 3
May/June 2017
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Quantitative Microbial Risk Assessment of Pharmaceutical Products
Mostafa Essam Eissa
PDA Journal of Pharmaceutical Science and Technology May 2017, 71 (3) 245-251; DOI: 10.5731/pdajpst.2016.007047
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  • Article
    • Abstract
    • Introduction
    • Principles for the Risk Assessment from a Microbiologically Contaminated Batch
    • Detectability of Microbiologically Defective Samples (Pdet)
    • Severity and Frequency of Microbial Contaminant in Batch [(Σ Pinf)/N]
    • The Risk Probability Index and the Product Hazard Evaluation (Pri)
    • Conclusion
    • Conflict of Interest Declaration
    • Reference
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  • A Risk Based Approach for Pre-Use/Post-Sterilization Integrity Test Simulation During Bacterial Retention Testing as Part of the Process Specific Filter Validation of Sterilizing Grade Filters
  • Challenges and Solutions to Manufacturing of Low-Viscosity, Ultra-High Concentration IgG1 Drug Products: From Late Downstream Process to Final Fill Finish Processing
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Keywords

  • Microbiological quality
  • GMP
  • simulation study
  • Poisson distribution
  • Uncertainty Factor
  • dose-response model of infection

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Quantitative Microbial Risk Assessment of Pharmaceutical Products
Mostafa Essam Eissa
PDA Journal of Pharmaceutical Science and Technology May 2017, 71 (3) 245-251; DOI: 10.5731/pdajpst.2016.007047

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