Drug Res (Stuttg) 2024; 74(01): 18-23
DOI: 10.1055/a-2185-4916

Quality by Design in Pharmaceuticals: A Review of its Impact on Regulatory Compliance and Product Quality

Raja Shekhar Nunavath
1   Department of Pharmaceutical Analysis, JSS College of Pharmacy, JSS Academy of Higher Education & Research, Ooty, The Nilgiris, Tamil Nadu, India
Madhu Tanya Singh
2   Department of Pharmacology, JSS College of Pharmacy, JSS Academy of Higher Education & Research, Ooty, The Nilgiris, Tamil Nadu, India
Anubha Jain
3   Department of Pharmaceutical Chemistry, Shri Aurobindo College of Pharmacy, Indore, Madhya Pradesh, India
Marjita Chakma
4   Department of Pharmaceutics, College of Pharmacy, JSS Academy of Technical Education, Noida, Uttar Pradesh, India
Rajaguru Arivuselvam
5   Department of Pharmaceutical Biotechnology, JSS College of Pharmacy, JSS Academy of Higher Education & Research, Sri Shivarathreeshwara Nagar, Mysore, KA, India
Mohamed Sheik Tharik Abdul Azeeze
6   Department of Pharmaceutical Analysis, College of Pharmacy, JSS Academy of Technical Education, Noida, Uttar Pradesh, India
7   Department of Pharmaceutical Analysis, Faculty of Pharmacy, Karpagam Academy of Higher Education, Coimbatore, Tamil Nadu, India
› Author Affiliations


The pharmaceutical industry has embraced the quality-by-design (QbD) approach as a promising development, formulation and manufacturing strategy. QbD provides a systematic and science-based framework for designing and producing high-quality products, with a particular focus on identifying, assessing and controlling risks throughout the development process. This review aims to assess the benefits of implementing QbD in pharmaceutical processes, evaluate its impact on regulatory compliance and explore its potential to enhance drug product quality. The primary objective of this review is to evaluate the influence of QbD on pharmaceutical development and manufacturing processes. It also seeks to examine the regulatory requirements associated with the implementation of QbD and highlight the advantages of this approach in terms of product quality and cost-effectiveness. Additionally, the review aims to explore the potential of QbD in improving the safety and efficacy of drug products. The QbD approach holds tremendous potential to revolutionize the pharmaceutical industry by optimizing drug development & manufacturing processes, reducing costs and enhancing product quality and consistency. However, implementing QbD requires a comprehensive understanding of the underlying science, as well as strict adherence to regulatory requirements in drug development and manufacturing. In conclusion, by embracing the QbD approach, the pharmaceutical industry can ensure the production of safe, effective and regulation-compliant products while simultaneously improving process efficiency. This strategic shift toward QbD represents a pivotal step in advancing pharmaceutical research and manufacturing capabilities, ultimately benefiting both the industry and more importantly, patients worldwide.

Supplementary Material

Publication History

Received: 19 July 2023

Accepted: 21 September 2023

Article published online:
22 December 2023

© 2023. Thieme. All rights reserved.

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