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Quality by Design: A Review on Modern Approach for Quality of Pharmaceuticals

K Vanitha, Sheetal Shastry, Y. Navya

Abstract


Quality by design (QbD) is the present-day approach to ensure the safety and efficacy of pharmaceuticals. In this review, the quality by design is described and some of its elements are identified to ensure quality of pharmaceuticals. Process parameters and quality attributes are identified for each unit operation. The benefits, possibilities, and steps engaged in quality by design of pharmaceutical products are outlined in this article. The quality guidelines Q8, Q9, Q10 given by ICH for pharmaceutical development, quality risk management, pharmaceutical quality systems respectively, gives application of quality by design in pharmaceutical development and their manufacturing. The aim of the pharmaceutical development is to design a quality product and its manufacturing process to consistently deliver the intended performance of the product with good quality. Measures should be taken to add or enhance the quality of product throughout its development. It includes the Quality target product profile, critical quality attributes and other key aspects of Quality by Design. QbD also gives the comparison between quality of product by end-product testing and quality of product by quality by design. Quality by Design is the aspect explained and given in international conference for harmonization.


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References


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