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World Journal of Pharmaceutical Research (WJPR) will give best paper award in every issue in the form of money along with certificate to promote research activity of scholar.
            Best Paper Award :
Dr. Muhammad Baqir MR Fakhrildin
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Abstract

QUALITY BY DESIGN: A NEW CONCEPT IN PHARMACEUTICAL PRODUCT DEVELOPMENT

*Rajveer Bhaskar, Monika Ola, Ram Choure and Prakash Patil

ABSTRACT

Quality by Design (QbD) refers to a new approach in product
development that could increase efficiencies, provide regulatory relief
and flexibility throughout the product life cycle. It supports both
industry and FDA to move towards a more scientific, risk based,
holistic and proactive approach to pharmaceutical development.
During designing and development of a product in QbD, a company
needs to define desire product performance profile [Target Product
Profile (TPP), Target Product Quality Profile (TPQP)] and identify
critical quality attributed (CQA). The company then designs the
product formulation and processes to meet the product attributes. This
leads to understanding the impact of raw materials [Critical Material
Attributes (CMA)], on the CQAs and identifies and control sources of variability. This
systematic approach to product development and manufacturing has received a great deal
from the traditional approach, which was extremely empirical. QbD is necessary in regulatory
requirement and to implement new concepts such as design space.

Keywords: Quality by design, Quality target product profile, Critical quality attributes, Design of experiment, Pharmaceutical manufacturing, Quality risk management, Design space.


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