114 . BLOCKCHAIN INTEGRATION IN PHARMACEUTICAL VALIDATION: A FUTURE PERSPECTIVE

Authors

  • Devkumar Darshan Rajpuriya USA Author

Keywords:

Blockchain Technology, Data Integrity, Pharmaceutical Validation, Regulatory Compliance, Supply Chain Management

Abstract

The pharmaceutical industry faces ongoing challenges in maintaining data integrity, ensuring compliance with regulatory requirements, and establishing transparent supply chain management. This technical article examines the transformative potential of blockchain technology in pharmaceutical validation processes, with particular emphasis on FDA 21 CFR Part 11 compliance. Through analysis of current implementations and theoretical frameworks, we explore how blockchain's inherent characteristics can revolutionize pharmaceutical validation while addressing existing industry pain points, focusing on consensus mechanisms, smart contracts, and system integration. The article demonstrates significant improvements in audit efficiency, compliance management, and data accessibility through blockchain implementation, providing a roadmap for future industry adoption.

References

Blue Line Technologies Research Report, "The Digital Transformation of Pharmaceutical Manufacturing," 2024. Available: https://blue-line.com/digital-transformation-pharmaceutical-manufacturing

Abhijeet Ghadge, et al., "Blockchain implementation in pharmaceutical supply chains: A review and conceptual framework," International Journal of Production Research, 2022. Available: https://www.tandfonline.com/doi/full/10.1080/00207543.2022.2125595#d1e197

Shannan Liu, et al., "P-PBFT: An improved blockchain algorithm to support large-scale pharmaceutical traceability," Computers in Biology and Medicine, 2023. Available: https://www.sciencedirect.com/science/article/pii/S0010482523000550

Abidemi A. Emmanuel, et al., "A Hybrid Framework of Blockchain and IoT Technology in the Pharmaceutical Industry: A Comprehensive Study," Journal of Healthcare Engineering, 2023. Available: https://onlinelibrary.wiley.com/doi/10.1155/2023/3265310

Manasi S. Zade, et al. "Blockchain technologies in pharmaceutical industry: A comprehensive overview" International Journal of Current Advanced Research in Pharmacy, 2024. Available: https://www.ijcap.in/html-article/21330

Dhika Prameswari et al., "Automation in the Pharmaceutical Industry: Al Evolution," Pharmaceutical Engineering Journal, 2024. Available: https://pharmeng.com/automation-in-the-pharmaceutical-industry-al-evolution/

V. Pareek, et al., "Blockchain Technology in Pharmaceutical Industry," Scripta Medica Journal, 2024. Available: https://scriptamedica.com/wp-content/uploads/2024/06/10-SM-553-PAREEK-et-al..pdf

Mark Gaynor, et al. "Blockchain Applications in the Pharmaceutical Industry," Blockchain in Healthcare Today, 2024. Available: https://blockchainhealthcaretoday.com/index.php/journal/article/view/298/542

Abhijeet Ghadge, "Blockchain implementation in pharmaceutical supply chains: A review and conceptual framework," International Journal of Production Research, 2024. Available: https://www.researchgate.net/publication/363184977_Blockchain_implementation_in_pharmaceutical_supply_chains_A_review_and_conceptual_framework

Gaurav Kumar Badhotiya, et al., "Investigation and assessment of blockchain technology adoption in the pharmaceutical supply chain," International Journal of Production Research, 2021. Available: https://www.researchgate.net/publication/349588763_Investigation_and_assessment_of_blockchain_technology_adoption_in_the_pharmaceutical_supply_chain

Binariks Research Report, "How Predictive Analytics Shapes Pharma's Future," 2024. Available: https://binariks.com/blog/predictive-analytics-in-pharmaceutical-industry/

Salam Abdallah, et al., "Blockchain-based solution for Pharma Supply Chain Industry," Computers & Industrial Engineering, 2024. Available: https://www.sciencedirect.com/science/article/abs/pii/S0360835223000219

Published

2025-01-30

How to Cite

Devkumar Darshan Rajpuriya. (2025). 114 . BLOCKCHAIN INTEGRATION IN PHARMACEUTICAL VALIDATION: A FUTURE PERSPECTIVE. INTERNATIONAL JOURNAL OF COMPUTER ENGINEERING AND TECHNOLOGY, 16(01), 1553-1566. https://ijcet.in/index.php/ijcet/article/view/299