A Review on Implementing Quality by Design

Nikita K. Gaydhane, Manisha P. More, Vinayal V. Thombale, Gayatri M. Polakhare, Ruchita R. Tale, Ravindra L. Bakal


Quality by Design is the modern approach for quality of pharmaceuticals. Recent pharmaceutical regulatory documents have stressed the critical significance of applying quality by design (QbD) principles for in-depth process understanding to guarantee that product quality is built in by design. Quality has been given a significance by all regulatory body for pharmaceutical goods. Quality means customer fulfillment in terms of service, products, and process. QbD is a systematic approach to product or method development that begins with predefined objectives and uses science and risk management approaches to achieve product and method understanding and finally method control. The aim of the analytical QbD is to attain quality in measurement. Under this concept of QbD throughout designing and development of a product, it is essential to define desire product performance profile [Target product profile (TPP), Target product Quality profile(TPQP) and identify Critical quality attributed (CQA). On the basis of this we can design the product formulation and the process to meet the product attributes. These leads to recognize the impact of raw material [Critical material attributes (CMA), Critical process parameter (CPP), on the CQA’s and identification and source of variability. This paper gives idea about the Pharmaceutical Quality by Design (QbD) and describes use of Quality by Design to guarantee quality of Pharmaceutical products. The Quality by Design is described and some of its elements identified


Quality, Design, pharmaceutical

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