Bars

Major GMP Guidlines

• ICH Guidelines

• ICH Q7 Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients

• ICH Q8(R2) Pharmaceutical Development

• ICH Q9 Quality Risk Management

• ICH Q10 Pharmaceutical Quality System

• Eudralex Volume 3 ICH Guideline Q11 on Development and Manufacture of Drug Substances (Chemical Entities and Biotechnological/Biological Entities)