Smart Pharmaceutical Manufacturing: Ensuring End-to-End Traceability and Data Integrity in Medicine Production

Production lines in pharmaceutical manufacturing generate numerous heterogeneous data sets from various embedded systems which control the multiple processes of medicine production. Such should arguably ensure end-to-end traceability and integrity order to release a batch, is uniquely identified tracked by its batch number/code. Consequently, auditable computerised are crucial on production lines, since industry becoming increasingly regulated for product quality patient health purposes. This paper describes EU-funded SPuMoNI project, aims large amounts produced representative environments. Our initial results include significant progress in: (i) verification taking advantage blockchain properties smart contracts authenticity, transparency, immutability; (ii) assessment models identify behavioural patterns that can violate practices and/or international regulations; (iii) intelligent agents collect manipulate as well perform decisions. By analysing sensors work centres, laboratories, our approach has been initially evaluated using industry-grade generated at an IT environment with inspected regulatory government agencies.