Module 3 2019

Guidance on Starting materials

▪ ICH Q11 (2011) Development and Manufacture of Drug Substances (chemical entities and biotechnological/biological entities)

▪ CPMP guideline on the chemistry of new active substances (CPMP/QWP/130/96, Rev 1)

▪ QWP Reflection Paper (2014) on the requirements for selection and justification of starting materials for the manufacture of chemical active substances – retired

▪ ICH Q 11 Q&A 2018 intended to provide additional clarification on requirements of ICH Q11

The Organisation for Professionals in Regulatory Affairs