Optimizing Quality Standards in Pharma 4.0 by Implementing Quality Behaviors for Excellence in the Digital Era
Literature Review
DOI:
https://doi.org/10.55175/cdk.v52i2.1329Keywords:
Data integrity, Pharma 4.0, quality behaviorAbstract
The pharmaceutical industry is undergoing a significant transformation with the emergence of the Pharma 4.0 concept, driven by technological advancements such as the internet of things (IoT), artificial intelligence (AI), and robotic production systems (continuous manufacturing). One crucial aspect of this transformation is the need for strong data integrity (DI) to ensure the data reliability and security related to pharmaceutical product quality. In the era of Pharma 4.0, performance data from the pharmaceutical industry can be integrated to support real-time decision-making, the presence of DI is crucial to protect consumers and comply with industry regulations. The ALCOA+ principle is used to ensure the integrity of data throughout its lifecycle, including identification, sustainability, and availability of data. Quality behavior is needed to enhance self-awareness in the 4.0 transformation, especially with the increasing focus on cybersecurity and the rising number of data integrity cases, particularly in implementing the ALCOA+ principle. Quality behavior becomes crucial in addressing the challenges and opportunities presented by the Pharma 4.0 transformation and in maintaining data integrity in pharmaceutical industry.
Downloads
References
Arden NS, Fisher AC, Tyner K, Yu XL, Lee SL, Kopcha M. Industry 4.0 for pharmaceutical manufacturing: Preparing for the smart factories of the future. Internat J Pharmaceutics. 2021;602:1-2. DOI: 10.1016/j.ijpharm.2021.120554.
Haleem MR, Saleem YM, Fatahallah FA, Abdelfattah EL. Quality in the pharmaceutical industry. Saudi Pharmaceut J. 2015;23:466. DOI: 10.1016/j.jsps.2013.11.004.
Alosert H, Savery J, Rheaume J, Cheeks M, Turner R, Spencer C, et al. Data integrity within the biopharmaceutical sector in the era of industry 4.0. Biotechnol J. 2022;17:2-4. DOI: 10.1002/biot.202100609.
Zarour M, Alenezi M, Ansari MTJ, Pandey AK, Ahmad M, Agrawal A, et al. Ensuring data integrity of healthcare information in the era of digital health. Healthc Technol Lett. 2021 Apr 16;8(3):66-77. DOI: 10.1049/htl2.12008.
Jaiswal H, S BM, Kulyadi GP. Data integrity violations: A challenge to the pharmaceutical industry. IJPQA. 2019;11(1):193-5. DOI:10.25258/ijpqa.11.1.30.
FDA. Warning letter intas pharmaceutical limited [Internet]. 2023; MARCS-CMS 662868. Available from: https://fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/intas-pharmaceuticals-limited-662868-11212023.
Anwar RW. Behavior based quality program [Internet]. 2023 Jun 26. Available from: https://www.linkedin.com/pulse/behavior-based-quality-program-raja-waheed-anwar-.
WHO. Behavioral sciences for better health initiative. Seventy Fifth World Health Assembly. 2022 .
BPOM RI. Peraturan Badan Pengawas Obat dan Makanan Nomor 13 tahun 2018 tentang Perubahan Atas Peraturan Kepala Badan Pengawas Obat dan Makanan Nomor HK.03.1.33.12.12.8195 Tahun 2012 tentang Penerapan Pedoman Cara Pembuatan Obat yang Baik. 2018.
FDA. Culture of quality data integrity at the center of patient-focused generic drug development, SBIA generic drugs forum [Internet]. 2022. Available from: https://www.fda.gov/media/165534/download.
Turley L. An introduction to behavior based quality [Internet]. 2015. Available from: https://www.linkedin.com/pulse/introduction-behavior-based-quality-liam-turley.
WHO. TRS 986 - Annex 2: WHO good manufacturing practices for pharmaceutical products: Main principles [Internet]. 2014 Oct 01. Available from: https://www.who.int/publications/m/item/trs986-annex2.
Kavasidis I, Lallas E, Leligkou, HC, Oikonomidis G, Karydas D, Gerogiannis VC, et al. Deep transformers for computing and predicting ALCOA+ data integrity compliance in the pharmaceutical industry. Appl Sci. 2023;13:1-3. DOI: 10.3390/app13137616.
Suprin M, Chow A, Pillwein M, Rowe J, Ryan M, Zbikowska BZ, et al. Quality risk management framework: Guidance for successful implementation of risk management in clinical development. Sage J. 2019;53(1):37. DOI: 10.1177/2168479018817752.
European Medicines Agency. ICH guideline Q9 (R1) on quality risk management.[Internet]. 2023 Jul 26. Available from: https://www.ema.europa. eu/en/ich-q9-quality-risk-management-scientific-guideline.
Downloads
Published
How to Cite
Issue
Section
License
Copyright (c) 2025 Steffen Thomas, Rusli Ananta
This work is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License.
