Based  on  EMA  Questions  and  answers  on  implementation  of  risk-based  prevention  of  cross– contamination  in production  and ‘Guideline  on setting health-based  exposure  limits for  use in risk  identification  in  the  manufacture  of  different  medicinal  products  in  shared  facilities’, (EMA/CHMP/CVMP/SWP/246844/2018)

“The  toxicological  or  pharmacological  data  on  which  the  HBEL  calculation  relies,  requires periodical reassessment throughout a product’s lifecycle”.