Module 3 2019

Starting materials (SM): Key issues

One of the most frequent Major Objections: ▪ Short synthetic routes ▪ Custom-synthesised starting materials ▪ Few synthetic steps (esterification, salt formation, protection / deprotection) ▪ Insufficient information to assess: ▪ the suitability of SM specification/analytical controls ▪ the impact of material quality to the upstream synthesis and the quality of final drug substance ▪ the introduction and carryover of impurities

▪ Information on key synthetic steps omitted or SM defined late stage beyond significant chemical transformations

The Organisation for Professionals in Regulatory Affairs