Abstract

BRIEF REVIEW ON QUALITY BY DESIGN

Miss. Mohini S. Jogdande* and Dr. Sachin A. Nitave

Abstract

Regulatory authorities consider that incremental and unsystematic improvement in unit operations, in isolation, would only have little effect on overall process performance or quality. To assure the quality of the product, a more holistic approach provided by QbD should be adopted. QbD is defined in the ICH Q8 guideline as “a systematic approach to development that begins with predefined objectives and emphasizes product and process understanding and process control, based on sound science and quality risk management”. Furthermore, for technology transfer, QbD generated process understanding can make the transition more efficient ICH Q9 together with ICH Q8 and Q10 is one of the ICH Q-topics that encourage further development science based and risk based approaches to quality. The intention of ICH Q9 is to focus the behaviors of industry and regulatory authorities on the two primaries.

Keywords: Quality, QbD, ICH, Emphasizes.