Implementing Quality by Design (QbD): Strategies, Challenges, and Best Practices across Industries

Year : 2024 | Volume :15 | Issue : 02 | Page : 28-36
By

Patil Divyashree Kantilal,

Mahale Devendra S,

Amit Kumar R Dhankani,

Mansi A Dhankani,

Sunil P. Pawar,

  1. Student M Pharm Department of Pharmaceutical Quality Assurance, P.S.G.V.P. Mandal’s College of Pharmacy Maharashtra India
  2. Student M Pharm Department of Pharmaceutical Quality Assurance, P.S.G.V.P. Mandal’s College of Pharmacy Maharashtra India
  3. Assistant Professor Department of Pharmaceutical Quality Assurance, P.S.G.V.P. Mandal’s College of Pharmacy Maharashtra India
  4. Assistant Professor Department of Pharmaceutics, P.S.G.V.P. Mandal’s College of Pharmacy Maharashtra India
  5. Principal P.S.G.V.P. Mandal’s College of Pharmacy Maharashtra India

Abstract

The present comprehensive review investigated the dynamic landscape of quality standards within the pharmaceutical sector, with a primary focus on the implementation and impact of Quality by Design principles. It illuminated the multifaceted challenges encountered by pharmaceutical companies in upholding stringent quality standards amidst evolving regulatory requirements and complex manufacturing processes. By embracing Quality by Design principles, the industry aims to foster a proactive and systematic approach to product development and manufacturing, thereby enhancing product quality, safety, and efficacy while mitigating risks. Central to the Quality by Design framework is the concept of critical quality attributes, which are vital characteristics of a drug product that ensure its desired performance and therapeutic effectiveness. Through a thorough understanding of critical quality attributes, pharmaceutical companies can design robust control strategies and implement riskbased approaches to ensure consistent product quality throughout the product lifecycle. Moreover, the adoption of Quality by Design principles necessitates a paradigm shift in regulatory expectations, with agencies such as the International Conference on Harmonization and the United States Food and Drug Administration advocating for a more science-based and integrated approach to quality management. The use of cutting-edge techniques and technologies, such as Process Analytical Technology and Design of Experiments, is essential to the effective application of Quality by Design. Pharmaceutical producers may now methodically identify and adjust key process parameters, improving process robustness, process comprehension, and product quality control; thanks to these cutting-edge methodologies. Furthermore, the present review underscored the importance of integrating Quality by Design principles into the broader product development lifecycle, from early-stage formulation development to commercial manufacturing. By embedding Quality by Design principles into every stage of the development process, pharmaceutical companies can streamline operations, accelerate time-tomarket, and ultimately deliver safer and more effective medicines to patients worldwide. Overall, the present review offered valuable insights into the transformative role of Quality by Design in shaping the future of pharmaceutical quality assurance and regulatory compliance.

Keywords: Pharmaceutical industry, Quality by Design (QbD), Critical quality attributes (CQAs), Regulatory landscape, Risk assessment.

[This article belongs to Research & Reviews: A Journal of Pharmaceutical Science(rrjops)]

How to cite this article: Patil Divyashree Kantilal, Mahale Devendra S, Amit Kumar R Dhankani, Mansi A Dhankani, Sunil P. Pawar. Implementing Quality by Design (QbD): Strategies, Challenges, and Best Practices across Industries. Research & Reviews: A Journal of Pharmaceutical Science. 2024; 15(02):28-36.
How to cite this URL: Patil Divyashree Kantilal, Mahale Devendra S, Amit Kumar R Dhankani, Mansi A Dhankani, Sunil P. Pawar. Implementing Quality by Design (QbD): Strategies, Challenges, and Best Practices across Industries. Research & Reviews: A Journal of Pharmaceutical Science. 2024; 15(02):28-36. Available from: https://journals.stmjournals.com/rrjops/article=2024/view=152173



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Regular Issue Subscription Review Article
Volume 15
Issue 02
Received April 8, 2024
Accepted May 23, 2024
Published June 26, 2024

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