Abstract

QUALITY BY DESIGN - NOVELTY IN PHARMACEUTICALS

Shajeeya Amren. Sk*, Viswanath. A, Srinivasa Babu. P.

Vignan pharmacy college, vadlamudi, Guntur-522213 A.P., India.

Abstract

Quality by design is an essential part of the modern approach to pharmaceutical quality. Quality by Design (QbD) is everything u do to directly to promote and prove safety efficacy and quality of your product from proof of concept to the point at which costumer are buying on regular basics. A new approach to drug development could increase efficiencies, provide regulatory relief and flexibility, and offer important business benefits throughout the product’s life cycle. QbD has become the answer to assist both industry and FDA to move towards a more scientific, risk based, holistic and proactive approach to pharmaceutical development. The concept promotes industry’s understanding of the product and manufacturing process starting with product development, basically building quality in, not testing it. As results of all understanding, a company can continually monitor and update its manufacturing process to assure consistent product quality. Using QbD, pharmaceutical quality is assured by understanding and controlling formulation and manufacturing variables. Product testing confirms the product quality. This systematic approach to product development and manufacturing has received a great deal from traditional approach, which was extremely empirical. Implementation of QbD is enabling transformation of the chemistry, manufacturing, and controls (CMC) review of Abbreviated New Drug Applications (ANDAs) into a modern, science and risk based pharmaceutical quality assessment.

Keywords: quality by design, ICH Q8, ICH Q9, ICH Q10.