Background: In pharmaceutical terms, quality means a product free from any contamination
and delivers the therapeutic benefit specified in the label at a reproducible rate which can
be assessed by carrying out in vivo or in vitro tests for evaluation of performance. Quality by Design
(QbD) is a necessary tool in pharmaceutical environment for having product/process/method
impregnated with quality. QbD is a move toward drug development that ensures the preplanned
product specifications by providing guidance for architecting the manufacturing processes and
Methodology: It has provided the solution to support both the regulatory bodies and industry to
shift towards added proactive and scientific approach. QbD is the greatest solution to construct
quality in all pharmaceutical products, while at the same time, making it a part of the system is
also a key challenge for the industry. By using QbD concept, regulators as well as industries are
making a move in geometric progress in bringing quality products. Regulatory bodies across the
world are showing significant attention to QbD.
Conclusion: Therefore, an attempt has been made to highlight quality by designing generic drugs
and its implications to pharmaceutical industry including clinical trials, pharmaceutical validation
processes and in biologics and also to provide a brief description on the status of QbD in India and
as well as in Asia.