References
- Abdallah, S., & Nizamuddin, N. (2023). Blockchain-based solution for pharma supply chain industry. Computers & Industrial Engineering, 177, 108997. https://doi.org/10.1016/j.cie.2023.108997
- Arslan, M. Y. (2019). Leveraging OEE tracker tool to address efficiency losses of packaging lines resulting from track & trace compliance in the pharmaceutical industry.
- Basu, P., Joglekar, G., Rai, S., Suresh, P., & Vernon, J. (2008). Analysis of manufacturing costs in pharmaceutical companies. Journal of Pharmaceutical Innovation, 3(1), 30–15. https://doi.org/10.1007/s12247-008-9024-4
- Bellefontaine, S., & Lee, C. (2014). Between black and white: Examining grey literature in meta-analyses of psychological research. Journal of Child and Family Studies, 23(8), 1378–1388. https://doi.org/10.1007/s10826-013-9795-1
- Bellm, D. (2015). Operational excellence in the pharmaceutical industry – An architecture for emerging markets to obtain the title of Doctor of philosophy in management submitted by Daniel Bellm from Germany approved on the application of Prof. Dr Thomas Friedli and Prof. Dr Wolfgang Stölzle Dissertation No. 4331 Difo-Druck GmbH, Bamberg 2015 the University Of St.Gallen, School of Management, Economics, Law, Social Sciences and International Affairs Hereby Consents to the Printing of The. St. Gallen University: University of St.Gallen, School of Management, Economics, Law, Social Sciences and International Affairs. Available at: (Retrieved: June 22, 2020) https://www1.unisg.ch/www/edis.nsf/SysLkpByIdentifier/4331/$FILE/dis4331.pdf.
- Bird, R. C., & Chaudhry, P. E. (2009). Pharmaceuticals and the European Union: Managing gray markets in an uncertain legal environment. Virginia Journal of International Law, 50, 719.
- Borges, A. Reimagining the ‘E’ in OEE in the packaging industry | packaging strategies. Packaging Strategies. Available at: (Accessed: 15 April. 2023). https://www.packagingstrategies.com/articles/95809-reimagining-the-e-in-oee-in-the-packaging-industry.
- Buckley, G. J. (2013). The effects of falsified and substandard drugs. National Academies Press (US) Available at: (Retrieved: April 8, 2023) https://www.ncbi.nlm.nih.gov/books/NBK202526/.
- Butschli, J. (2017). Serialization implementation improves par pharma’s efficiency. Packaging world, 3 August. Available at:(Retrieved: May 25, 2020) https://www.packworld.com/issues/operational-excellence/article/13373125/serialization-implementation-improves-par-pharmas-efficiency.
- Casali, N. (2019). College of Engineering and Management Master of Science in Engineering and Management Master of Science Thesis Increasing the OEE of an Oral Solutions Production Line by Applying Lean Manufacturing Tools Supervisor: Candidate: Domenico Augusto Maisano Casali Nicolas April 2019 [ Masters Thesis Thesis]. POLITECNICO DI TORINO. https://webthesis.biblio.polito.it/10613/1/tesi.pdf.
- Center for Drug Evaluation and Research. (2018). Available at: (Retrieved: July 18, 2020) https://www.fda.gov/regulatory-information/search-fda-guidance-documents/product-identifiers-under-drug-supply-chain-security-act-questions-and-answers.
- Charitable Trusts, P., & Allen Hamilton, B. (2013). Implementing a Pharmaceutical serialization and traceability system in the United States.
- Chatterjee, B. (2014). Applying lean six sigma in the pharmaceutical industry (1st ed.). Routledge. https://doi.org/10.4324/9781315567419
- Chiacchio, F. (2019). Towards a blockchain-based traceability process: A case study from pharma industry. In Advances in Production Management Systems. Production Management for the Factory of the Future: IFIP WG 5.7 International Conference, APMS 2019, Austin, TX, USA, September 1–5, 2019, Proceedings, Part I. Springer, pp. 451–457.
- Cockburn, R., Newton, P. N., Agyarko, E. K., Akunyili, D., & White, N. J. (2007). Correction: The Global Threat of Counterfeit Drugs: Why Industry and Governments Must Communicate the Dangers. PLoS medicine, 4(9), e289. https://doi.org/10.1371/journal.pmed.0040289
- Commission of the European Communities. (2008a). Available at: https://ec.europa.eu/health/sites/health/files/files/pharmacos/pharmpack_12_2008/counterfeit-ia_en.pdf.
- Commission of the European Communities. (2008b). Commission staff working document Accompanying Document to the Proposal for a DIrective of the European parliament and of the council amending directive 2001/83/ec as regards the prevention of the entry into the legal supply chain of medicinal products which are falsified in relation to their identity, history or source impact. Commission of the european communities. Available at: (Retrieved: June 18, 2020). https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:52008SC2674&from=en.
- Cordon, C., Garcia-Milà, P., Ferreiro Vilarino, T., & Caballero, P. (2016). Serialization in the Pharmaceutical Industry. In Strategy is Digital. Management for Professionals. Cham: Springer. https://doi.org/10.1007/978-3-319-31132-6_3
- Deloitte. (2012). Vaccine 2D Barcoding for Manufacturers - IIS | CDC. www.CDC.gov. Available at: (Retrieved: April 8, 2023). https://www.cdc.gov/vaccines/programs/iis/2d-barcodes/manufacturers.html.
- de Ron, A. J., & Rooda, J. E. (2006). OEE and equipment effectiveness: An evaluation. International Journal of Production Research, 44(23), 9–15. https://doi.org/10.1080/00207540600573402
- Discover, C. I. (2020). TEVA | Inventory Turnover Chart and History 2017-2020 | DiscoverCi. Available at: (Retrieved: August 2, 2020). https://www.discoverci.com/companies/TEVA/inventory-turnover.
- EFPIA. (2012). EFPIA Individual Response. Coding & Serialisation Delegated Act on the Detailed Rules for a Unique Identifier for Medicinal Products for Human Use, and Its Verification Concept Paper Submitted for Public Consultation EFPIA Individual Response. EFPIA Available at: (Retrieved: July 14, 2020). https://ec.europa.eu/health/sites/health/files/files/falsified_medicines/2012-06_safety-features/efpia_en.pdf.
- EUIPO. and OECD. (2019). Trends in trade in counterfeit and pirated goods. OECD Publishing, Paris/European Union Intellectual Property Office Available at: (Retrieved: July 5, 2020). https://euipo.europa.eu/tunnel-web/secure/webdav/guest/document_library/observatory/documents/reports/trends_in_trade_in_counterfeit_and_pirated_goods/trends_in_trade_in_counterfeit_and_pirated_goods_en.pdf.
- EUIPO. and OECD. (2020). Trade in counterfeit pharmaceutical products. Available at: (Retrieved: June 17, 2020). https://euipo.europa.eu/tunnel-web/secure/webdav/guest/document_library/observatory/documents/reports/Trade_in_Counterfeit_Pharmaceutical_Products/Trade_in_Counterfeit_Pharmaceutical_Products_en.pdf.
- European Commission. (2008). 2007 REPORT on community customs activities on counterfeit and piracy results at the European border - 2007 2 European Commission — Taxation and Customs Union. (Retrieved June 22, 2020). Available at: https://ec.europa.eu/taxation_customs/sites/taxation/files/resources/documents/customs/customs_controls/counterfeit_piracy/statistics2007.pdf.
- European Commission. (2012). 2011 Report on Community Customs Activities on Counterfeit and Piracy Results at the European Border. (Retrieved June 22, 2020). Available at: https://ec.europa.eu/taxation_customs/sites/taxation/files/resources/documents/customs/customs_controls/counterfeit_piracy/statistics/2012_ipr_statistics_en.pdf.
- European Commission. (2017). EudraLex - volume 4 - Good Manufacturing Practice (GMP) guidelines - public health - European commission. Public Health. (Retrieved December 16, 2018). Available at: https://ec.europa.eu/health/documents/eudralex/vol-4_en.
- European Commission. (2019). 2018 report on community customs activities on counterfeit and piracy results at the European border - 2018 2 European commission — taxation and customs union. Available at: (Retrieved: June 22, 2020) https://ec.europa.eu/taxation_customs/sites/taxation/files/2019-ipr-report.pdf.
- European commission Enterprise + Industry. (2008). Counterfeit Medicines - Responses to Public Consultation (2008). (Retrieved July 14, 2020). Available at: https://web.archive.org/web/20090109020934/http://ec.europa.eu/enterprise/pharmaceuticals/counterf_par_trade/counterfeit_consult_2008.htm#i.
- European Medicines Agency. (2018). European Medicines Agency Recommends Measures to Manage Contamination of Heparin-Containing Medicines. (Retrieved July 3, 2020). Available at: https://www.ema.europa.eu/en/news/european-medicines-agency-recommends-measures-manage-contamination-heparin-containing-medicines.
- European Medicines Verification System. (2023). EMVO. (Retrieved April 8, 2023). Available at: https://emvo-medicines.eu/.
- Europol. (2020). €7.9 Million of Illegal Products Seized in A Hit Against Medicine Traffickers. (Retrieved June 29, 2020). Available at: https://www.europol.europa.eu/print/newsroom/news/%E2%82%AC79-million-of-illegal-products-seized-in-hit-against-medicine-traffickers.
- Fortier, S., & Joevan, A. (2017). How serialization can improve drug manufacturing operations. Manufacturing Engineering;.
- Foundation, P., & Allen Hamilton, B. (2014). PEW booz allen hamilton report evaluating the economic impact of item serialization. Available at: (Retrieved: July 19, 2020) https://www.pewtrusts.org/-/media/assets/2014/04/29/boozallenhamiltonreport.pdf.
- Griffith, C. M., Rondoletto, N., & Hamed, F. (2010). Genentech journey to operational excellence 2004 - 2009. In The pathway to operational excellence in the pharmaceutical industry – overcoming the internal inertia (pp. 135–137). University of St. Gallen. Available at. https://www.swisscleanroomconcept.ch/UserFiles/File/ECV%20Leseproben/the-pathway-to-operational-excellence.pdf
- GS1 AISBL. (2013). Available at: (Retrieved: July 12, 2020). https://www.gs1ie.org/download_files/healthcare_files/gs1-datamatrix-in-healthcare.pdf.
- GS1 Ireland. (2023). Pharma Serialisation and the EU Falsified Medicines Directive. (Retrieved April 15, 2023). Available at: https://www.gs1ie.org/healthcare/sectors/pharma/pharma-serialisation-and-the-eu-falsified-medicines-directive.html.
- Gyurjyan, G. (2017). Rethinking Pharma Productivity | McKinsey. Available at: (Retrieved: April 15, 2023). https://www.mckinsey.com/industries/life-sciences/our-insights/rethinking-pharma-productivity.
- Hall, C. (2012). Technology for combating counterfeit medicine. Pathogens and Global Health, 106(2), 73–76. https://doi.org/10.1179/204777312X13419245939485
- Harris, G., & Bogdanich, W. (2008). Drug tied to china had contaminant, FDA Says. The New York Times, 6 March. Available at: (Retrieved: July 3, 2020). https://www.nytimes.com/2008/03/06/health/06heparin.html.
- Hayes, R. H., & Wheelwright, S. C. (1984). ‘Restoring our competitive edge: Competing through manufacturing’. (Retrieved July 25, 2020). Available at: https://www.hbs.edu/faculty/Pages/item.aspx?num=47196.
- Hubbard, W. K. (2009). Can the food and drug administration ensure that our pharmaceuticals are safely manufactured? Archives of Internal Medicine, 169(18), 1655–1656. https://doi.org/10.1001/archinternmed.2009.304
- International Federation of Pharmaceutical Manufacturers and Associations. (2023). Falsified Medicines. IFPMA. (Retrieved April 8, 2023). Available at: https://ifpma.org/areas-of-work/improving-health-security/falsified-medicines/.
- ISO. (2006). (Retrieved July14, 2020). Available at: https://www.sis.se/api/document/preview/907850/.
- Jablonski, J., & Brochu, D. (2006). Manufacturing business intelligence technology drives operational excellence.
- Lahjouji, M. (2023). A systematic literature review: The power of the blockchain technology to improve pharmaceutical supply chain. Journal of Theoretical & Applied Information Technology, 101(2), 952–971.
- Liang, B. (2006). Parallel trade in pharmaceuticals: injecting the counterfeit element into the public health. North Carolina Journal of International Law, 31(4), 847.
- Mackey, T. K., Cuomo, R., Guerra, C., & Liang, B. A. (2015). After counterfeit Avastin®—what have we learned and what can be done? Nature Reviews Clinical Oncology, 12(5), 302–308. https://doi.org/10.1038/nrclinonc.2015.35
- Mahood, Q., Van Eerd, D., & Irvin, E. (2014). Searching for grey literature for systematic reviews: challenges and benefits. Research Synthesis Methods, 5(3), 221–234. https://doi.org/10.1002/jrsm.1106
- Mankins, M. (2017). Great companies obsess over productivity, not efficiency. Harvard Business Review, 1 March. (Retrieved July 30, 2020). Available at: https://hbr.org/2017/03/great-companies-obsess-over-productivity-not-efficiency.
- Manufacturing, P. (2007). Benchmarking shows need to improve uptime, capacity utilization. Pharma Manufacturing. (Retrieved June 21, 2020) Available at: https://www.pharmamanufacturing.com/articles/2007/144/.
- Mossinghoff, G. J. (1999). Overview of the Hatch-Waxman act and its impact on the drug development process. Food and Drug Law Journal, 54(8), 952–971.
- Nakajima, S. (1988). Introduction to TPM: Total productive maintenance. Translation).
- Nalam, R. (2023). Systematic review of pharmaceutical drugs serialization. Systematic Review of Pharmaceutical Drugs Serialization, 120(1), 9–9. https://doi.org/10.47119/IJRP1001201320234507
- Nguyen, A., Bougacha, O., Lekens, B., Lamouri, S., Pellerin, R., & Couvreur, C. (2023). On the use of logistics data to anticipate drugs shortages through data mining. Procedia Computer Science, 219, 949–956. https://doi.org/10.1016/j.procs.2023.01.371
- OECD/EUIPO. (2020). Trade in counterfeit pharmaceutical products, illicit trade. OECD Publishing. https://doi.org/10.1787/a7c7e054-en
- O’Mahony, D. (2020), The Impact of Serialisation on Operational Efficiency and Productivity in Irish Pharmaceutical Sites. Griffith College. Available at: https://go.griffith.ie/427/1/77792_Daniel_OMahony_Dan_O_Mahony_Dissertation_Submission_2976250_216874_802618486%201.pdf.
- Ozkaya, E., Wizard, S. C., & LLC. (2017). Digital Factory Transformation Beyond Serialization Compliance. Pharmaceutical Commerce. Available at: (Retrieved: July 17, 2020). https://pharmaceuticalcommerce.com/manufacturing-and-packaging/digital-factory-transformation-beyond-serialization-compliance/.
- Pappas, C., & Williams, I. (2011). Grey Literature: Its Emerging Importance. Journal of Hospital Librarianship, 11(3), 228–234. https://doi.org/10.1080/15323269.2011.587100
- Penfold, A. W. (2018). How to Minimize Impact on Overall Equipment Effectiveness (OEE). ISPE | International Society for Pharmaceutical Engineering. Available at: (Retrieved: April 8, 2023) https://ispe.org/pharmaceutical-engineering/ispeak/how-to-minimize-impact-overall-equipment-effectiveness-oee.
- Pharmaceutical Security Insitute. (2023). Incident Trends. PSI. (Retrieved April 8, 2023). Available at: https://www.psi-inc.org/incident-trends.
- Pharma Logistics IQ. (2017) Pharmaceutical Serialization and Traceability: 2017 Trend Report. Pharma Logistics. Available at: (Retrieved: April 8, 2023) https://www.pharmalogisticsiq.com/supply-chain-security-track-trace/whitepapers/pharmaceutical-serialization-and-traceability-2017
- Pirrera, V., & Jordan, J. (2014). Reclaiming Efficiency Amid Serialization Nightmares. Available at: https://www.vantage-cg.com/wp-content/uploads/2018/07/serialization-nightmares.pdf.
- Pisani, E. (2017). (978-92-4-151342–5) WHO Global Surveillance and Monitoring System for Substandard and Falsified Medical Products. World Health Organization. (Retrieved June 20, 2020). Available at: https://apps.who.int/iris/bitstream/handle/10665/326708/9789241513425-eng.pdf?ua=1.
- IRACM, & Przyswa, E. (2013). Counterfeit Medicines and Criminal Organizations. International Institute of Research Against Counterfeit Medicines. (Retrieved June 30, 2020). Available at: http://fightthefakes.org/wp-content/uploads/2013/11/Rapport-Etude_IRACM_Contrefacon-de-Medicaments-et-Organisations-Criminelles_EN_FINALs2.pdf.
- Rajora, N. (2023). (2) ‘Essence controls in pharmaceutical enterprise systems’. International Journal of Science and Research Archive, 8(2), 012–017. https://doi.org/10.30574/ijsra.2023.8.2.0197
- Ramesh, A. (2015). “Bridging the value chain”–The pedigree way.
- Robinson, P. (2013). Evaluation of the Impact of 2D Barcodes on Vaccine Secondary Packaging. Center for Immunization and Respiratory Diseases Immunization Services Division Centers for Disease Control and Prevention: CDC. (Retrieved July 19, 2020). Available at: https://www.cdc.gov/vaccines/programs/iis/2d-vaccine-barcodes/downloads/secondary-packaging-evaluation.pdf.
- Rodgers, D. (2014). Impact on Production Line Speeds and OEE. (Retrieved July 17, 2020). Healthcare Packaging Available at: https://www.healthcarepackaging.com/issues/traceability-serialization/article/13288019/impact-on-production-line-speeds-and-oee.
- Rodgers, D. (2015) Serialization Playbook. Healthcare Packaging. Available at: https://www.healthcarepackaging.com/logistics-distribution/logistics-supply-chain/document/13686132/serialization-playbook (Accessed: 8 April).
- Rotunno, R., Cesarotti, V., Bellman, A., Introna, V., & Benedetti, M. (2014a). Impact of track and trace integration on pharmaceutical production systems. International Journal of Engineering Business Management, 6, 25. https://doi.org/10.5772/58934
- Rotunno, R., Cesarotti, V., Bellman, A., Introna, V., & Benedetti, M. (2014b). Impact of track and trace integration on pharmaceutical production systems. International Journal of Engineering Business Management, 6, 9. https://doi.org/10.5772/58934/
- Sarkar, S. (2022). Pharmaceutical serialization: A challenge for small manufacturers. International Journal of Scientific Research in Computer Science, Engineering and Information Technology, 8(4), 174–181. https://doi.org/10.32628/CSEIT228428
- Schonberger, R. J. (2007). Best Practices in Lean Six Sigma Process Improvement: A Deeper Look | Wiley. (Retrieved July 25, 2020). Wiley Available at: https://www.wiley.com/en-us/Best+Practices+in+Lean+Six+Sigma+Process+Improvement%3A+A+Deeper+Look-p-9780470168868.
- Shanley, A. (2016). Serialization: Getting past the quick fix. BioPharm, 40(1), 65–68. https://www.pharmtech.com/view/serialization-getting-past-quick-fix
- Singh, R. K., Kumar, R., & Kumar, P. (2016). Strategic issues in pharmaceutical supply chains: A review. International Journal of Pharmaceutical and Healthcare Marketing, 10(3), 234–257. https://doi.org/10.1108/IJPHM-10-2015-0050
- Spector, R. (2018). Lean Laggards: Exploring the State of Lean in Pharma. Pharma Manufacturing. (Retrieved July 27, 2020). Available at: https://www.pharmamanufacturing.com/articles/2018/lean-laggards-exploring-the-state-of-lean-in-pharma/.
- Starke, V., & Kumor, J. (2013). Abbott pharmaceuticals journey of business excellence standards. In T. Friedli, P. Basu, D. Bellm, & J. Werani (Eds.), Leading pharmaceutical operational excellence: Outstanding practices and cases (pp. 153–168). Springer Berlin Heidelberg. https://doi.org/10.1007/978-3-642-35161-7_11
- Trajanovska, I., Pavicevic, B., Brezovska, K., Jolevska, S. T., & Ribarska, J. T. (2023). Principles and methods used in the serialization process of the medicines. Macedonian Pharmaceutical Bulletin, 68(1), 203–204. https://doi.org/10.33320/maced.pharm.bull.2022.68.03.097
- Vander Beken, T., & Balcaen, A. (2006). ‘Crime opportunities provided by legislation in market sectors: mobile phones, waste disposal, banking, pharmaceuticals. European Journal on Criminal Policy and Research, 12(3), 299–323. https://doi.org/10.1007/s10610-006-9025-0
- Vernon, J. A., Hughen, W. K., & Trujillo, A. J. (2007). Pharmaceutical manufacturing efficiency, drug prices, and public health: examining the causal links. Drug Information Journal, 41(2), 229–239. https://doi.org/10.1177/009286150704100217
- Werani, J., Bellando Randone, G., & Goetzfried, M. (2010). Making operational excellence work – training and coaching supporting behavioral change. In The pathway to operational excellence in the pharmaceutical industry – overcoming the internal inertia (p. 10). University of St. Gallen. https://www.swisscleanroomconcept.ch/UserFiles/File/ECV%20Leseproben/the-pathway-to-operational-excellence.pdf/
- WHO. (2003). Available at: https://web.archive.org/web/20041125080255/http://www.who.int/mediacentre/factsheets/fs275/en/print.html.
- WHO. (2013). WHO | Deadly Medicines Contamination in Pakistan. Available at: (Retrieved: July 4, 2020). https://www.who.int/features/2013/pakistan_medicine_safety/en/.
- Willis, M. (2017) ‘Data management: standards, security, integrity and analytics’.[PDF] Available at: https://www.researchgate.net/publication/322084122_Pharmaceutical_Serialisation_Data_Management.
- World Health Organisation. (2023). Substandard and Falsified Medical Products. WHO.int. Available at: (Retrieved: April 8, 2023). https://www.who.int/news-room/fact-sheets/detail/substandard-and-falsified-medical-products.