Published Paper Details:

Quality by Design is a novel concept to pharmaceutical quality. Pharmaceutical Quality by Design (QbD) is described in this paper, along with how it is used to ensure pharmaceutical quality. The Quality by Design concept is explained, and some of its components are listed. For and unit operation, process parameters and quality attributes are defined. It is impossible to evaluate quality. Quality cannot be measured into products; rather, it should be designed into them. Throughout the design and production of a product, it is essential to define the desired product performance profile [Target product profile (TPP), Target product Quality profile (TPQP), and identify Critical quality attributed (CQA) to the product under the QbD definition. We can design the product formulation and process to meet the product attributes based on this. These results in the recognition of the effect of raw material. [Critical material attributes (CMA), Critical process parameter (CPP)] on the CQAs, as well as the identification of uncertainty sources. This paper's application of the quality by design (QbD) aligns with the concepts of the ICH Q8, Q9, and Q10 guidelines.