ICH Quality Guidelines
ICH Quality Guidelines for pharmaceutical products,
Harmonisation achievements in the Quality area include pivotal milestones such as the conduct of stability studies, defining relevant thresholds for impurities testing and a more flexible approach to pharmaceutical quality based on Good Manufacturing Practice (GMP) risk management.
ICH Quality Guidelines available from Q1 to Q14
Click on the titles below for complete guidelines
Q5A - Q5E Quality of Biotechnological Products
Q7 Good Manufacturing Practice
Q10 Pharmaceutical Quality System
Q11 Development and Manufacture of Drug Substances
Q13 Continuous Manufacturing of
Drug Substances and Drug Products
Q14 Analytical Procedure Development
ICH Quality Guidelines Q1 to Q14 for pharmaceuticals
