An implementation of the design-by quality (QBD) approach in generic product development

In this study, it is aimed to use the basic principles of Quality by Design (QbD) approach to develop a generic product containing folic acid in tablet form and to determine the design space. The development process started with investigating the content of the reference product. Similar excipients used with reference product. Quality Target Product Profile (QTPP), which is the strategic basis of the development process, has been defined. Critical Quality Attributes (CQA) were determined by using the decision tree. Initial risk assessment of the developed generic products components was performed and as high-risk priority formulation components were determined. According to the initial risk assessment of the Critical Process Parameters (CPP), priority risky parameters were defined. Initial risk assessment Initial risk assessment was performed using Failure Mode and Effect Analysis (FMEA). Using the Minitab 18 program, a 2-level Plackett-Burman experiment design matrix was created for 7 factors, and 12 formulation trial studies were conducted according to the experimental designs and the results were analyzed. The effects of factors on the results of Dissolution Rate and Assay were examined. It was observed that the only factor that had a significant effect on the Dissolution Rate results was Tablet Hardness. It has been observed that there is no factor that has a significant effect on Assay. Design spaces were determined as a result of statistical analysis. Two Process Validation batches manufactured after determining of the final formula and flow chart. Process Validation Studies are verification study of the quality of the product. The analysis results of the Process Validation batches were compared with the reference product, it has been confirmed that a generic product similar to the reference product has been developed. Key Words: Quality by Design (QbD) Approach, Folic Acid, Tablet, Product Development, Statistical Analysis