Is There Any Method that could be used to define the significance of the health-based Exposure Limit (HBEL) such that there can be broad guidance on the extent of Quality Risk Management (QRM) and control measures required?
Is There Any Method that could be used to define the significance of the health-based Exposure Limit (HBEL) such that there can be broad guidance on the extent of Quality Risk Management (QRM) and control measures required?
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Firstly, it should be recognised that hazard varies on a continuum scale and that there are no firm cut off points, risk should be controlled on a proportionate basis. However, as a broad hypothetical model the following figure could be considered to show the increasing level of hazard (red being highest hazard) presented by products and there should be a commensurate increase in the level of control to prevent potential cross contamination in a shared facility. Actual HBEL values should be used in QRM studies to determine the actual controls required