Quality by design – A Systematic Approach to Enhance Quality Matrix

Abstract

Quality by design is utilized by the pharmaceutical industry to achieve quality products. This approach focuses on designing and developing products and processes to ensure predefined quality. It is a science-based approach that reduces product variation and enables process control strategies, improving process reliability and understanding. It is considered the sensible approach to minimizing batch failures, deviations, and expensive investigations. Quality by design (QbD) elements include quality target product profile, critical quality attributes, critical material attributes, critical process parameters, a control strategy that includes specifications for the drug substance(s), excipient(s), and process capability and continual improvement. Thus, the QbD is a modern approach to developing an effective and quality pharmaceutical product.