Module 3 Presentations

14/05/2024

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

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ICH Q11 Q&A Part 1 focuses on the proposed SM from its chemical structure perspective. Part 2 focuses on manufacturing steps which impact on the DS impurity profile and if enough of the manufacturing process is conducted under GMP

The Organisation for Professionals in Regulatory Affairs

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