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Asked: August 16, 20212021-08-16T12:47:40+02:00 2021-08-16T12:47:40+02:00In: Quality Assurance

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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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?

hbelhealthbased exposure limit
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    1. Qualistery Level 2
      2021-09-06T23:56:26+02:00Added an answer on September 6, 2021 at 11:56 pm

      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

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