Clinical Pharmacology & Biopharmaceutics
Open Access

Abstract

Quantitative Microbiological Risk Assessment (QMRA) is a valuable tool that has been used in the field of food industry and drinking water evaluation. This technique could be applied in the assessment of potential risk that may arise from the contamination of the medicinal products from manufacturing environment including pharmaceutical water on the final consumer. Another simple technique that can be used by the health care professionals was developed by using Quantitative Risk Index (QRI). This index was developed based on combination of factors that contribute to the final microbiological safety level of the drug. As the risk value increases the possibility of hazard delivered to the patient increases. The risk takes into account the infectivity of microorganisms for specific patient condition by certain route, their abundance in environment, manufacturing processes that are hostile to the viability of microbes, antimicrobial power of the product including water activity, the volume or batch size of the dedicated drug, the maximum single dose that can be delivered to the patient and the general trend of microbial count. The newly applied risk showed primarily agreement with QMRA in the ranking of risks that is associated with specific bacteria under study. However, the expanding gap between the continually increasing number of objectionable microbes and the lack of the exact data about infective dose for human by specific route of each objectionable bug is rising and requires an extensive care by healthcare scientists to understand the risk associated with each microorganisms and not only the common pathogens.

Biography

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