ICH Quality Guidelines Overview

• Quality Guidelines

   

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.

• Stability Q1A - Q1F

• Analytical Validation Q2

• Impurities Q3A - Q3D

• Pharmacopoeias Q4 - Q4B

• Quality of Biotechnological Products Q5A - Q5E

• Specifications Q6A- Q6B

• Good Manufacturing Practice Q7

• Pharmaceutical Development Q8

• Quality Risk Management Q9

• Pharmaceutical Quality System Q10

• Development and Manufacture of Drug Substances Q11

• Cross-cutting Topics

Posted in: ICH