Alosert, Haneen;
Savery, James;
Rheaume, Jennifer;
Cheeks, Matthew;
Turner, Richard;
Spencer, Christopher;
S Farid, Suzanne;
(2022)
Data integrity within the biopharmaceutical sector in the era of Industry 4.0.
Biotechnology Journal
, Article e2100609. 10.1002/biot.202100609.
(In press).
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Abstract
Data Integrity (DI) in the highly regulated biopharmaceutical sector is of paramount importance to ensure decisions on meeting product specifications are accurate and hence assure patient safety and product quality. The challenge of ensuring DI within this sector is becoming more complex with the growing amount of data generated given increasing adoption of process analytical technology (PAT), advanced automation, high throughput microscale studies, and managing data models created by machine learning (ML) tools. This paper aims to identify DI risks and mitigation strategies in biopharmaceutical manufacturing facilities as the sector moves towards Industry 4.0. To achieve this, the paper examines common DI violations and links them to the ALCOA+ principles used across the FDA, EMA, and MHRA. The relevant DI guidelines from the ISPE's GAMP5 and ISA-95 standards are also discussed with a focus on the role of validated computerised and automated manufacturing systems to avoid DI risks and generate compliant data. The paper also highlights the importance of DI whilst using data analytics to ensure the developed models meet the required regulatory standards for process monitoring and control. This includes a discussion on possible mitigation strategies and methodologies to ensure data integrity is maintained for smart manufacturing operations such as the use of cloud platforms to facilitate the storage and transfer of manufacturing data, and migrate away from paper-based records.
| Type: | Article |
|---|---|
| Title: | Data integrity within the biopharmaceutical sector in the era of Industry 4.0 |
| Location: | Germany |
| Open access status: | An open access version is available from UCL Discovery |
| DOI: | 10.1002/biot.202100609 |
| Publisher version: | https://doi.org/10.1002/biot.202100609 |
| Language: | English |
| Additional information: | © 2022 The Authors. Biotechnology Journal published by Wiley-VCH GmbH This is an open access article under the terms of the Creative Commons Attribution License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited. |
| Keywords: | Industry 4.0, PAT, biochemical engineering, bioprocess manufacturing, data analytics, data integrity |
| UCL classification: | UCL > Provost and Vice Provost Offices > UCL BEAMS > Faculty of Engineering Science UCL > Provost and Vice Provost Offices > UCL BEAMS > Faculty of Engineering Science > Dept of Biochemical Engineering UCL > Provost and Vice Provost Offices > UCL BEAMS UCL |
| URI: | https://discovery.ucl.ac.uk/id/eprint/10146758 |
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