Abstract

ANALYTICAL APPROACH ON QUALITY BY DESIGN

Monika Jadhao*

ABSTRACT

Analytical methods play important role supporting implementation of QbD in process Pharma-cuticle development and development and manufacturing. Analytical testing also plays pro-minent role in Pharmaceutical development, risk assessment, process monitoring and control and continuous quality assessment throughout the product.[1] Quality-by-Design (QbD) is well-established in development and manufacture of pharmaceutical drug substance and drug product and is discussed in ICH Q8,[1] Q9[2] and Q2.[3] The same QbD approach can be applied to analytical procedures as per ICH Q2.

Keywords: .