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The purpose of present article is to discuss the concept of pharmaceutical Quality by Design (QbD) and describe how it can be help to ensure pharmaceutical quality. Quality by design is an essential part of the modern approach to pharmaceutical quality. The elements of quality by design are examined and a consistent nomenclature for quality by design, critical quality attribute, critical process parameter, critical material attribute, and control strategy is proposed. The use of QbD was contrasted with the evaluation of product quality by testing alone. The QbD is a systemic approach to pharmaceutical development. It means designing and developing formulations and manufacturing processes to ensure predefined product quality. Some of the QbD elements include defining target product quality profile, designing product and manufacturing processes, identifying critical quality attributes, process parameters, and sources of variability & controlling manufacturing processes to produce consistent quality over time. Using QbD, pharmaceutical quality is assured by understanding and controlling formulation and manufacturing variables.
Quality by design, elements, approach, critical quality attributes