When different medicinal products are produced in shared facilities, the potential for cross-contamination is a concern.
What needs to be considered?
Health based exposure limits (HBELs) should be established for all APIs of human and veterinary medicinal products manufactured in shared facilities.
PDE represents a substance-specific dose that is unlikely to cause an adverse effect if an individual is exposed at or below this dose every day for a lifetime.
The evaluation must be performed by a toxicologist, the expert CV and references shall be included in the report and must be reviewed on a regular basis according to the risk assessment and, after that, either reapproved or modified.
Each PDE report is prepared for a unique combination of compound (CAS Number) and administration route.
The HBEL should be reassessed periodically when significant data emerges that may affect the HBEL calculation and/or its assumptions.
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