Patil Divyashree Kantilal,
Mahale Devendra S,
Amit Kumar R Dhankani,
Mansi A Dhankani,
Sunil P. Pawar,
- Student M Pharm Department of Pharmaceutical Quality Assurance, P.S.G.V.P. Mandal’s College of Pharmacy Maharashtra India
- Student M Pharm Department of Pharmaceutical Quality Assurance, P.S.G.V.P. Mandal’s College of Pharmacy Maharashtra India
- Assistant Professor Department of Pharmaceutical Quality Assurance, P.S.G.V.P. Mandal’s College of Pharmacy Maharashtra India
- Assistant Professor Department of Pharmaceutics, P.S.G.V.P. Mandal’s College of Pharmacy Maharashtra India
- Principal P.S.G.V.P. Mandal’s College of Pharmacy Maharashtra India
Abstract
This comprehensive review investigates the dynamic landscape of quality standards within the pharmaceutical sector, with a primary focus on the implementation and impact of Quality by Design (QbD) principles. It illuminates the multifaceted challenges encountered by pharmaceutical companies in upholding stringent quality standards amidst evolving regulatory requirements and complex manufacturing processes. By embracing QbD 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 QbD framework is the concept of critical quality attributes (CQAs), which are vital characteristics of a drug product that ensure its desired performance and therapeutic effectiveness. Through a thorough understanding of CQAs, pharmaceutical companies can design robust control strategies and implement risk-based approaches to ensure consistent product quality throughout the product lifecycle. Moreover, the adoption of QbD principles necessitates a paradigm shift in regulatory expectations, with agencies such as the International Conference on Harmonization (ICH) and the United States Food and Drug Administration (FDA) 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 (PAT) and Design of Experiments (DoE), is essential to the effective application of QbD. 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, this review underscores the importance of integrating QbD principles into the broader product development lifecycle, from early-stage formulation development to commercial manufacturing. By embedding QbD principles into every stage of the development process, pharmaceutical companies can streamline operations, accelerate time-to-market, and ultimately deliver safer and more effective medicines to patients worldwide. Overall, this review offers valuable insights into the transformative role of QbD 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)]
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Research & Reviews: A Journal of Pharmaceutical Science
| Volume | 15 |
| Issue | 02 |
| Received | April 8, 2024 |
| Accepted | May 23, 2024 |
| Published | June 26, 2024 |
