Abstract

A REVIEW ON: QUALITY BY DESIGN APPROACH TO ANALYTICAL METHOD DEVELOPMENT

Pratiksha B. Sonawane*, Ramanlal N. Kachave and M. J. Chavan

Abstract

QbD is the latest approach to pharmaceuticals quality. QbD is gaining a lot of publicity for maintaining quality among the pharmaceutical industries. It functions as a bridge between industry and drug regulatory authorities to transfer towards scientific, risk-based pharmaceutical product development. It has been decided that during the manufacturing process quality of pharmaceutical product should be designed and built. Most of the quality concerns are connected to the manner in which pharmaceutical products have been manufactured. Poorly designed pharmaceutical products can demonstrate poor safety and effectiveness, no matter how many experiments or analyses have been performed to validate their performance. Thus, QbD starts with quality and does not merely improve by expanding pharmaceutical research. The concept of QbD is focused on enhancement of process and product understanding with the help of risk assessment, identifying critical quality attributes and critical process parameters to be controlled via right control strategy. In the review, QbD and its elements are given. Benefits, opportunities and steps involved in QbD of pharmaceutical products are described. It also gives application of QbD in pharmaceutical development and manufacturing of pharmaceuticals.

Keywords: QBD, FDA, ATP, CQA, NDA, ANDA, BLAs, PAT, QTPP, MODR, CAPA, DOE.