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

Raja Shekhar Nunavath; Madhu Tanya Singh; Anubha Jain; Marjita Chakma; Rajaguru Arivuselvam; Mohamed Sheik Tharik Abdul Azeeze

doi:10.1055/a-2185-4916

Drug Research, Inhaltsverzeichnis

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

Review

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

Raja Shekhar Nunavath

¹Department of Pharmaceutical Analysis, JSS College of Pharmacy, JSS Academy of Higher Education & Research, Ooty, The Nilgiris, Tamil Nadu, India

,

Madhu Tanya Singh

²Department of Pharmacology, JSS College of Pharmacy, JSS Academy of Higher Education & Research, Ooty, The Nilgiris, Tamil Nadu, India

,

Anubha Jain

³Department of Pharmaceutical Chemistry, Shri Aurobindo College of Pharmacy, Indore, Madhya Pradesh, India

,

Marjita Chakma

⁴Department of Pharmaceutics, College of Pharmacy, JSS Academy of Technical Education, Noida, Uttar Pradesh, India

,

Rajaguru Arivuselvam

⁵Department of Pharmaceutical Biotechnology, JSS College of Pharmacy, JSS Academy of Higher Education & Research, Sri Shivarathreeshwara Nagar, Mysore, KA, India

,

Mohamed Sheik Tharik Abdul Azeeze‡

⁶Department of Pharmaceutical Analysis, College of Pharmacy, JSS Academy of Technical Education, Noida, Uttar Pradesh, India

⁷Department of Pharmaceutical Analysis, Faculty of Pharmacy, Karpagam Academy of Higher Education, Coimbatore, Tamil Nadu, India

› Institutsangaben

Abstract

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.

Key words

Cost-effective Methods - Drug development - Design Space Concept - Pharmaceutical Processes - Quality by Design - Regulatory Compliance.

Volltext

Referenzen

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