World Journal of
Pharmaceutical and Life Sciences

QUALITY BY DESIGN: ITS APPLICATIONS

*T. Anusha, Shyamala and J. V. C. Sharma

ABSTRACT

Quality design (QBD) is a modern and systematic approach for product development and quality of pharmaceuticals. Quality by design is a concept first outlined by well known quality expert Joseph M. Juran. QBD is best key to build a quality in all pharmaceutical products, it is important to identify desire product performance report.QBD has it perspective to contribute the drug design, development, and manufacture of high quality drug product. Now-a –days the concept of Qbd can be extended to analytical techniques. In this analytical concept it is essential to define desire product performance profile, analytical target profile [ATP], identify critical quality attributes throughout designing and development process. The review aimed to identify implementation of QBD in analytical procedure validation. The outcomes of organized analytical process development and validation understand of critical quality attributes, risk assessment and outlining design space, and control strategy. The Quality by design is based on the ICH guidelines Q8 for pharmaceutical for development, Q9 Quality risk management, Q10 for pharmaceutical quality systems.

[Full Text Article]   [Download Certificate]