ABSTRACT
The words “Quality by Design” (QbD) have become synonymous with pharmaceutical process improvement. QbD has seemingly assumed pervasive and even mystical proportions in the media as it has evolved from a conceptual initiative to a “panacea” for improving pharmaceutical development and manufacturing. The paradigm shift or change in orientation toward adoption and application of QbD principles has been acknowledged by several companies who have incorporated the approach as an integral part of their business. The competent quality management system ensures “effective monitoring and control systems for process performance and product quality, thereby providing assurance of continued suitability and capability of processes”. This includes knowledge management and quality risk management “by providing the means for science and risk-based decisions related to product quality”. The importance of understanding the therapeutic expectations for the product cannot be underestimated. The connection between the quality of the product and its impact on safety and efficacy for the patient is paramount.
