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Applied Clinical Research, Clinical Trials and Regulatory Affairs

Author(s): Deepika Purohit, Manisha Saini, Parijat Pandey, Swagat Tripathy and Harish Dureja*

DOI: 10.2174/2213476X06666190117120029

Cite As
Implementation of Quality by Design: A Review

Page: [99 - 111] Pages: 13

  • * (Excluding Mailing and Handling)

Abstract

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 formulation.

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.

Keywords: Quality by design, critical material attribute, critical process parameter, quality profile, target product, target product profile.

Graphical Abstract

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