Abstract

PHARMACEUTICAL QUALITY BY DESIGN [QBD]

Sneha S. Vairagkar*, Wasmate D., Lasure A.B., Bawage S.B. and Nandkishor B. Bawage

ABSTRACT

The concept of "Quality by Design" (QBD) is gaining a lot of attention among the pharmaceutical industry in order to maintain quality. It serves as a bridge between the regulatory authorities of the drug and drug industry to advance the scientific, risk-based, comprehensive and effective path to drug development. In particular it combines design and development design and production processes to ensure the quality of the previously defined product. Some of the features of QBD include defining the quality profile of the intended product, designing product and production processes, identifying critical quality attributes, process parameters, and diversification sources and managing production processes to produce consistent quality over time. ensuring drug quality and drug development.

Keywords: Design by Design (QBD), Quality target Product Profile (QTPP), Critical Quality Attribute (CQA), Critical Process Parameter (CPP), Quality Risk Management (QRM).