ABSTRACT
Blockchain technology is omnipresent. While it may not be directly associated with the pharmaceutical industry, its potential for supporting GxP processes cannot be overlooked. Blockchain, known for its decentralized and distributed nature, employs elements such as cryptography, consensus, smart contracts, and replication to capture and secure data from multiple participants in a network. Acting as a decentralized and immutable ledger, blockchain records transactions in blocks linked together through cryptography. It can serve as a distributed database and the ultimate source of truth for the entire system. Various types of blockchains exist, including public, consortium, and permissioned or private blockchains, each offering different levels of accessibility and control. This technology operates on different layers, with Layer 1 (L1) constituting the foundational chain and Layer 2 (L2) solutions enhancing scalability and transaction processing. This article delves into the intersection of blockchain technology and the pharmaceutical industry, highlighting the importance of comprehending the application and intended use of blockchain to adopt a risk-based approach.