ICH Q9

ICH Q9 is a guideline developed by the International Conference on Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) for applying quality risk management principles to pharmaceutical manufacturing and development. It offers a framework for identifying, assessing, and mitigating risks to product quality across all stages of a product’s lifecycle.

The FDA has adopted ICH Q9, and its principles are integrated into regulatory requirements. All ICH member health authorities are required as signatories to ICH to adopt its guidelines or at least their principles into their regulatory frameworks.

ICH Q9 emphasizes a risk-based approach to decision-making, ensuring that resources are focused on areas with the highest potential impact on product quality and patient safety.

The guideline suggests tools like Failure Mode and Effect Analysis (FMEA) and Hazard Analysis and Critical Control Points (HACCP) to systematically assess risks.

For more details on ICH Q9, read ICH Q9 Quality Risk Management in Pharma.