Health-Based Exposure Limits (PDE & OEL)

Pharmaceuticals-PDE-OEL-Toxicological-Assessment

  • Determination of a PDE in compliance with EMA/CHMP/CVMP/SWP/169430/2012 guidelines:

    • Hazard identification by reviewing all relevant data

    • Identification of “critical effects”

    • Determination of the no-observed-adverse-effect level (NOAEL)

    • Use of appropriate adjustment factors

  • Calculation of Occupational Exposure Limits (OEL) to minimize worker exposure to hazardous substances

  • Compliance with regulatory guidelines and frameworks such as EMA, OSHA, ACGIH, NIOSH, and ECHA

  • Determine the maximum acceptable carryover (MACO) values - Cleaning validation

Frequently Asked Questions

  • Permitted Daily Exposure (PDE) represents the maximum daily dose of a substance unlikely to cause adverse effects, even with lifetime exposure. PDE is typically expressed in mg/kg body weight and derived according to European Medicines Agency (EMA) and International Council for Harmonisation (ICH) guidelines.

  • Occupational Exposure Limit (OEL) defines the airborne concentration of a substance that workers can be exposed during a specific time period without adverse health effects. OELs are expressed in mg/m³ or ppm and derived following ECHA and other international occupational safety guidelines.

  • PDEs prevent cross-contamination in shared manufacturing facilities and are used to calculate Maximum Allowable Carryover (MACO) in cleaning validation. OELs protect worker health by ensuring airborne exposures remain within acceptable safety thresholds. Together, they support product safety, worker safety, and regulatory compliance.

  • MACO (Maximum Allowable Carryover) represents the maximum residue of a product that can safely carry over into the next product during manufacturing. It is calculated from PDE values and is critical for cleaning validation, cross-contamination prevention, and maintaining product quality.

  • SciQra’s DABT- and ERT-certified toxicologists provide scientifically defensible PDE and OEL assessments, calculate MACO values, and prepare regulatory-ready toxicological justifications. We ensure compliance across EU, US, and global requirements. contact us for assistance with PDE/OEL derivation and MACO calculations.