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- Published online May 26, 2017.
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- previous version (December 14, 2016 - 05:03).
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© PDA, Inc. 2017
Author Information
- Mostafa Essam Eissa*
- HIKMA Pharma for Pharmaceutical Industry, 2nd Industrial Zone, 1st Plot, 6th of October City, Giza, Egypt, P.O. 13311
- ↵* Corresponding Author: Mostafa Essam Eissa, Quality Compliance Department, Hikma Pharma Pharmaceutical Company, Egypt. Telephone: +20100 615 4853; e-mail: mostafaessameissa{at}yahoo.com
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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
- Figures & Data
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