What Are the Key Guidelines Issued by EMA for Catalysis?
The EMA has issued several guidelines that impact the use of catalysis in drug development and manufacturing. These include:
ICH Q11 - Development and Manufacture of Drug Substances ICH Q7 - Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients ICH Q8 - Pharmaceutical Development
These guidelines provide a framework for ensuring that catalytic processes are consistent, reproducible, and compliant with regulatory standards.
