- As highlighted in the GMP guideline revised by EMA on June 01 2015, companies that manufacture different medicinal products in shared production facilities must set Permitted Daily Exposure (PDE) Limits for health risk identification.
Companies that manufacture different multiple medicinal products in shared production areas should have PDE values for their products for the cleaning validation approach.
- PDE reports are requested during local and international authority inspections in your facility. PDE values are calculated based on the ICH Guideline (Q3D) dated February 4, 2011.
- PDE values are obtained using scientific NO(A)EL or LO(A)EL results of animal studies.
- PDE Calculation takes place in 4 steps;
- Phase 1: Hazard Identification
- Stage 2: Critical Effects
- Phase 3: NOEL Identification
- Phase 4: Implementation of Security Factors
PDE Calculation: NO(A)EL x Weight is variable is divided by various adjustment factors (also known as safety-, uncertainty-, assessment-, or modifying factors) in order to adjust the data for uncertainties and to allow extrapolation to human population (or target animal population).