Question

Assessment, control, communication, and review of risks to the quality of the drug product across the product life cycle is:

• A. \( \text{QbD} \)
• B. \( \text{QRM} \)
• C. \( \text{PAT} \)
• D. \( \text{QTPP} \)

Hint:

QRM enhances pharmaceutical decision-making by integrating risk assessments into drug development and quality control.

Answer 1

The Correct Option is B

Quality Risk Management (QRM) involves identifying, assessing, and controlling risks associated with drug quality throughout its lifecycle. It ensures continuous monitoring to maintain compliance with regulatory standards while optimizing pharmaceutical manufacturing and development. QRM is integral to quality assurance processes, reducing failures and variability in drug products.