Blockchain for Data Originality in Pharma Manufacturing

• Published in: Journal of pharmaceutical innovation 2023-12, Vol.18 (4), p.1745-1763
• Main Authors: Durá, Marta, Leal, Fátima, Sánchez-García, Ángel, Sáez, Carlos, García-Gómez, Juan M., Chis, Adriana E., González-Vélez, Horacio
• Format: Article
• Language: English
• Subjects: Biochemical Engineering; Biomedical and Life Sciences; Biomedicine; Biotechnology; Industrial and Production Engineering; Original Article; Pharmacology/Toxicology
• ISSN: 1872-5120; 1939-8042
• DOI: 10.1007/s12247-023-09748-z

Purpose This paper analyses the feasibility of tracking data originality for pharmaceutical manufacturing in a tamper-proof manner using a geographically distributed system. The main research question is whether it is possible to ensure the traceability of drug manufacturing through the use of smart contracts and a private blockchain network. Methods This work employs a private Ethereum network with a proof-of-authority consensus algorithm to allow participating nodes to commit the medicament manufacturing originality as transactions in blocks. We use smart contracts to assess the “Original” principle of the ALCOA+ data integrity principles for full sensor-enabled production lines within pharmaceutical manufacturing plants. We have evaluated our data originality assessment approach employing a temporal series of 1300 reports generated based on real datasets from pharma production lines. Out of these reports, 300 reports have been randomly tampered with to make them “unoriginal” (i.e., falsified). Results Evaluation consistently shows that the proposed approach systematically detects all the manufacturing records whether original or not, together with any source of falsification. By randomly injecting four common data falsification types, their approach effectively detects tampering and ensures the authenticity of the data originality acquired by sensors within manufacturing lines. Conclusion The approach of using a private blockchain network with a proof-of-authority consensus algorithm and smart contracts is a feasible method to track data originality for pharmaceutical manufacturing in a tamper-proof manner. In addition, this approach effectively detects tampering and ensures the authenticity of the data originality acquired by sensors within manufacturing lines.