28.11.2014

EMA Guideline for derivation of permitted daily exposures (PDEs) adopted

On 24.11.2014 EMA published the ‘Guideline on setting health based exposure limits for use in risk identification in the manufacture of different medicinal products in shared facilities’, which describes the derivation of ‘permitted daily exposures’ (PDE). PDEs are health-based values for evaluating cross-over of pharmaceuticals produced in shared facilities and for the quality assurance in the context of cleaning validation. Important: the revised version of Annex 15 of the Good Manufacturing Guidelines (GMP) ‘Qualification and Validation’, which will become effective in June 2015, obliges manufacturers to perform a risk assessment for cleaning validation using PDEs. If you have furter questions, you may contact Klaus Schneider.