Pharmaceutical product development: a “quality by design” (QbD) approach

Abstract

Quality by design (QbD) provides a new approach to pharmaceutical quality. This chapter provides extensive information on pharmaceutical QbD and how it can be used to ensure the quality of pharmaceuticals. In addition, the components of quality with design and the advantages, opportunities, and steps provided by quality with design are summarized. Pharmaceutical development aims to create a high-quality product and manufacturing method that consistently delivers the expected performance of the product. Quality cannot be tested into items, but it should be designed into them. It contains the quality goal product profile, critical quality attributes, and significant QbD features. It also compares product quality based on end-of-life testing to product quality based on QbD. The ICH Guidelines serve as the foundation for QbD. It is based on the ICH Guidelines Q8 and Q9 for pharmaceutical development, as well as Q10 for pharmaceutical quality systems. One of the most fundamental steps of QbD, design of experiment (DoE) analysis is used to significantly reduce the number of experiments required to build a model design space. The right tools for design space development are determined from many aspects, including the complexity of the system under study and scientific data. Therefore in this chapter, the basic steps, principles, and types of experimental design are discussed in detail. As a result, this chapter has the feature that can be useful for any researcher who wants to know about QbD, which enables effective, efficient, and economical production in the field of pharmaceutical production. © 2024 Elsevier Ltd. All rights reserved.