Valutazione rischio microbiologico in ambiente farmaceutico

Gli aspetti principali da tenere in considerazione per la valutazione del rischio microbiologico in ambiente farmaceutico.

 

Si riporta quanto è stato evidenziato nella recente annuale Conferenza “Pharming” avvenuta a Nottingham, UK.

“The four main aspects to the risk assessment are:

-hazard identification

-hazard characterization

-risk characterization

-exposure assessment.

• Hazard identification.

Aims to characterize the importance of the organism to the product and should give the organism’s name, number and prevalence, resistance to intrinsic factors, virulence and toxigenesis.

• Hazard characterization

Aims to evaluate the nature of the adverse effect associated with the microbiological hazard. For this, consider the consumer and distinctive sub-groups, the severity of hazard, dose response assessment and hazardous level.

• Risk characterization

It gives the likelihood of adverse effects on consumption / use of the product.

• Exposure assessment

Evaluates the level of organism at the time of application or consumption.