World Journal of
Pharmaceutical and Life Sciences

( An ISO 9001:2015 Certified International Journal )

An International Peer Reviewed Journal for Pharmaceutical and Life Sciences
An Official Publication of Society for Advance Healthcare Research (Reg. No. : 01/01/01/31674/16)
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Abstract

EMERGING ACHIVEMENTS OF QUALITY BY DESIGN IN PHARMACEUTICAL INDUSTRY

Prof. Dandu Girija*, Basu Venkateswara Reddy, C. Siva Krishna, R. Kalyan kumar, G. Lakshmi, S. Mahesh

ABSTRACT

The present review mainly focused on a quality by design and its aspects in pharmaceutical industry and also deals with the elements in QbD and enablers of quality by design. Quality by design (QbD) is an innovative product development process approach using both existing knowledge and emerging science to identify key ?quality? issues. QbD is a systematic, scientific, risk based, holistic and proactive approach to pharmaceutical development that begins with predefined objectives and emphases product and processes understanding and process control. It is based on the ICH Guidelines Q8 for pharmaceutical development, Q9 for quality risk management, Q10 for pharmaceutical quality systems. It also gives application of Quality by Design in pharmaceutical development and manufacturing of pharmaceuticals.

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