Question

QbD is described in ICH guidelines:

• A. \( \text{Q8 Part I} \)
• B. \( \text{Q8 Part II} \)
• C. \( \text{Q9} \)
• D. \( \text{Q10} \)

Hint:

QbD enhances drug development by shifting focus from quality testing to proactive design and control strategies.

Answer 1

The Correct Option is A

Quality by Design (QbD) is outlined in ICH Q8 Part I, focusing on systematic pharmaceutical development. It emphasizes product understanding, design space, and control strategies to ensure consistent drug quality. QbD optimizes manufacturing processes by integrating scientific knowledge and risk assessment tools.