Rationale

Update E2500-20 to include best industry standards and most recent regulatory guidance including current updates to ICH Q9R1, EMA Annex 1 and 15, as well as best practices from PDA TR 54-5 on Quality Risk Management. Recent revisions of this standard were merely editorial exercises to maintain validity of this popular standard. This revision will embark on a ,major overhaul of the E2500 with wide consensus.