QbD Approach: A Framework for Integrating Quality into Pharmaceutical Products

Kharb, Monika and Rathore, Kamal Singh (2022) QbD Approach: A Framework for Integrating Quality into Pharmaceutical Products. Journal of Pharmaceutical Research International, 34 (12A). pp. 1-11. ISSN 2456-9119

[thumbnail of 5955-Article Text-8107-2-10-20221006.pdf] Text
5955-Article Text-8107-2-10-20221006.pdf - Published Version

Download (308kB)

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.

Item Type: Article
Subjects: Institute Archives > Medical Science
Depositing User: Managing Editor
Date Deposited: 06 Mar 2023 04:51
Last Modified: 17 Jun 2024 05:45
URI: http://eprint.subtopublish.com/id/eprint/1536

Actions (login required)

View Item
View Item