Glossary

ICH Q9

What is ICH Q9?

ICH Q9 is a guideline developed by the International Council for Harmonization (ICH) that provides a systematic approach to quality risk management (QRM) in the pharmaceutical industry.

What are the key objectives of ICH Q9?

Key Objectives of ICH Q9 include:

  • Enhance patient safety by managing risks to product quality
  • Ensure consistent product quality throughout the product lifecycle
  • Facilitate regulatory compliance and decision-making
  • Promote continuous improvement