Question

ICH Q9 refers to

• A. GMP guidelines
• B. Quality risk management
• C. Clinical safety
• D. Specifications

Hint:

ICH Q9 emphasizes quality risk management—essential for improving product safety and regulatory compliance.

Answer 1

The Correct Option is B

ICH Q9 guideline is focused on quality risk management in the pharmaceutical industry. It provides principles and tools for risk-based decision-making in quality systems, development, and manufacturing, ensuring better product quality and compliance.