QbD Approach: A Framework for Integrating Quality into Pharmaceutical Products

Abstract

Introduction: The traditional development processes use a quality by testing (QbT) approach that needs continuous testing to determine quality. Such processes are fixed, averse to change, and focus only on process reproducibility. This approach does not allow variation in material and process controls. In order to overcome the shortcomings of the traditional process, regulatory bodies have issued guidelines for the industries to improve the understanding of the process and the quality of the product. It aims to shift from traditional process QbT to a scientific approach quality by design (QbD) to assure product quality in the pharmaceutical industry. Methodology: Articles related to QbD published in many search engines such as Scopus, Google Scholar, and PubMed were reviewed. Review Findings: In order to ensure the quality of pharmaceutical products, regulatory bodies have emphasized on the implementation of QbD. For this, various guidelines have been published from time to time. The Indian pharmaceutical industry has started to apply the principles of QbD. Implementation of QbD develops a detailed understanding of the manufacturing process. The design space is achieved by QbD within which the expected quality is achieved even with changes in process parameters. Conclusion: In short, the QbD approach is a great tool for assuring pharmaceutical product quality and better understanding of the manufacturing process. Therefore, it is imperative to have a successful implementation of the QbD approach.