Pharmaceutical Quality by Design is a systematic approach to product development that starts with specified objectives and emphasizes product knowledge, methodologies, and operational procedures. It is based on trustworthy science and excellent risk reduction. Risk analysis is a beneficial science-based approach that may assist in discovering the material properties and production variables that may have an impact on the critical quality attributes of the finished product when it comes to high-quality risk management. An active pharmaceutical quality system comprises quality risk management nineteen. It can offer a pro-active strategy for identifying, objectively assessing, and managing possible quality issues. Throughout the course of the product’s lifetime, it enables ongoing better performance results and product quality enhancement. This review article discusses various Quality by Design methodologies for risk assessment during research and development.

Keywords: Quality by design, Risk assessment, Risk management, Pharmaceutical, Risk control, Failure mode