Research Journal of Pharmacy and Technology

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Implementation of Quality by Design Approach for Method Development and Validation: A Review


Affiliations
1 Research Scholar, College Of Pharmaceutical Sciences, Dayananda Sagar University, Bangalore-560078,, India
2 Associate Professor, College of Pharmaceutical Sciences, Dayanandasagar University, Bengaluru-560078, India
3 Professor and Dean, College of Pharmaceutical Sciences, Dayanandasagar University, Bengaluru-560078,, India
     

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QbD is the heart of recent pharmaceutical development. The implementation of QbD principles delivers a cost efficient methodology for delivering quality medicines for users. Regulatory agencies like USFDA and the European medicines agency (EMA) are placing the greater importance on a part of filing. QbD is efficient advances toward progress so as to commence through pre-defined aim and emphasizes manufacturing product and quality process understanding and method control depending on resonance knowledge and quality hazard supervision. Quality cannot be tested in the products but quality should be built by design, it is an essential part of modern approaches to pharmaceutical quality.under this concept of QbD throughout designing and development of a product. It is important to define the performance profile of the desired product, the quality profile of the target product, and identify critical quality attributes.

Keywords

Quality by design, Analytical method validation.
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  • Implementation of Quality by Design Approach for Method Development and Validation: A Review

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Authors

Sowmya HG
Research Scholar, College Of Pharmaceutical Sciences, Dayananda Sagar University, Bangalore-560078,, India
M. Gnana Ruba Priya
Associate Professor, College of Pharmaceutical Sciences, Dayanandasagar University, Bengaluru-560078, India
V. Murugan
Professor and Dean, College of Pharmaceutical Sciences, Dayanandasagar University, Bengaluru-560078,, India

Abstract


QbD is the heart of recent pharmaceutical development. The implementation of QbD principles delivers a cost efficient methodology for delivering quality medicines for users. Regulatory agencies like USFDA and the European medicines agency (EMA) are placing the greater importance on a part of filing. QbD is efficient advances toward progress so as to commence through pre-defined aim and emphasizes manufacturing product and quality process understanding and method control depending on resonance knowledge and quality hazard supervision. Quality cannot be tested in the products but quality should be built by design, it is an essential part of modern approaches to pharmaceutical quality.under this concept of QbD throughout designing and development of a product. It is important to define the performance profile of the desired product, the quality profile of the target product, and identify critical quality attributes.

Keywords


Quality by design, Analytical method validation.

References