BLOCKCHAIN FOR DATA INTEGRITY IN PHARMACEUTICAL QUALITY ASSURANCE: CURRENT LANDSCAPE AND FUTURE DIRECTIONS

Abstract

Data integrity is a fundamental rule of Good Manufacturing Practices (GMP) and Quality Assurance (QA) in the pharmaceutical industry which directly affects the level of product quality, safety of the patients, and compliance with the regulations. De-localized data systems that are conventional are prone to breach of regulations and compromise and inefficiency issues which expose them to risk of manipulation and loss of data too. Blockchain technology, and its two key attributes of decentralization, immutability, transparency, and cryptographic security, solutions to these problems are transformative. Blockchain is fully compatible with ALCOA+ principles (Attributable, Legible, Contemporaneous, Original, Accurate, and extensions) to compose tamper-evident, audit, and real-time records across the pharmaceutical value chain. Its uses include electronic batch records, change control, deviation management, audit trails, CAPA documentation, and supply chain traceability, and regulatory reporting. Moreover, smart contracts can help to adhere to the requirements of GMP automatically and avoid the risk of human error, increasing efficiency in the work. FDA, EMA, and WHO are also starting to appreciate the potential of blockchain, which reveals itself through pilot programs like MediLedger. Although it exists with several challenges like integration with legacy systems, cost, privacy, and a lack of global standardization, blockchain will transform QA systems with the power of predictive, data-driven, and proactive QA systems when combined with other Industry 4.0 technologies, such as IoT and AI. This review investigates the current trend of the blockchain as well as its probable applications, regulatory views, and future paths in pharmaceutical QA.