Identification and Classification of Risks in the Raw Material Procurement Process in the Pharmaceutical Industry
Abstract
In the pharmaceutical industry, identifying and managing process-related risks, particularly in the raw material procurement process, is of fundamental importance due to the critical role of these materials in ensuring product quality and production continuity. This study aims to comprehensively identify risks associated with the pharmaceutical raw material supply chain and to propose a process-based classification framework that enables managers and pharmaceutical industry professionals to conduct a structured and practical analysis of risks. This study began with a systematic review of the literature in reputable scientific and industrial databases, through which the risks reported in relevant studies on pharmaceutical raw material procurement were extracted. Subsequently, using a process map of raw material procurement (from inventory review, supplier identification, and supplier evaluation and selection to purchasing, transportation, and delivery to the production department) the identified risks were organized into risk categories associated with each stage of the process. The findings revealed that a considerable variety of operational, financial, logistical, organizational, environmental, and systemic risks can affect the raw material procurement process at different levels. The main outcome of this study is a process-oriented framework that can serve as a basis for developing risk assessment models, prioritizing control measures, and designing more accurate decision-making systems in the pharmaceutical industry. This framework can also provide a foundation for developing quantitative risk assessment models, including Bayesian networks, and for designing strategies to enhance the resilience of the pharmaceutical raw material supply chain in future research.
Keywords:
Risk identification, Pharmaceutical supply chain risk, Pharmaceutical supply chain process, Raw materials for productionReferences
- [1] Lee, H. L. (2002). Aligning supply chain strategies with product uncertainties. California Management Review, 44(3), 105–119. https://doi.org/10.2307/41166135
- [2] Prater, E. (2005). A framework for understanding the interaction of uncertainty and information systems on supply chains. International Journal of Physical Distribution & Logistics Management, 35(7), 524–539. https://doi.org/10.1108/09600030510615833
- [3] Wang, M. (2018). Impacts of supply chain uncertainty and risk on the logistics performance. Asia Pacific Journal of Marketing and Logistics, 30(3), 689–704. https://doi.org/10.1108/APJML-04-2017-0065
- [4] Azadeh, A., Salehi, V., Ashjari, B., & Saberi, M. (2014). Performance evaluation of integrated resilience engineering factors by data envelopment analysis: The case of a petrochemical plant. Process Safety and Environmental Protection, 92(3), 231–241. https://doi.org/10.1016/j.psep.2013.03.002
- [5] Jaberidoost, M., Nikfar, S., Abdollahiasl, A., & Dinarvand, R. (2013). Pharmaceutical supply chain risks: A systematic review. DARU Journal of Pharmaceutical Sciences, 21(1), 69. https://doi.org/10.1186/2008-2231-21-69
- [6] Schrijvers, D., Hool, A., Blengini, G. A., Chen, W. Q., Dewulf, J., & Eggert, R. (2020). A review of methods and data to determine raw material criticality. Resources, Conservation and Recycling, 155, 104617. https://doi.org/10.1016/j.resconrec.2019.104617
- [7] Tarigan, Y., & Mutmainah, S. S. (2023). Mitigation of supply chain risk management in supply of production raw materials using the house of risk (HOR) method. Jurnal Akuntansi, Ekonomi Dan Manajemen Bisnis, 11(1), 92–105. https://doi.org/10.30871/jaemb.v11i1.5133
- [8] Koh, R., Schuster, E. W., Chackrabarti, I., & Bellman, A. (2003). Securing the pharmaceutical supply chain. White Paper, Auto-ID Labs, Massachusetts Institute of Technology, 1, 19. https://web.mit.edu/edmund_w/www/MIT-AUTOID-WH021.pdf
- [9] Tang, C. S. (2006). Perspectives in supply chain risk management. International Journal of Production Economics, 103(2), 451–488. https://doi.org/10.1016/j.ijpe.2005.12.006
- [10] Lawrence, J. M., Hossain, N. U. I., Rinaudo, C. H., Buchanan, R. K., & Jaradat, R. (2022). An approach to improve hurricane disaster logistics using system dynamics and information systems. In Recent trends and advances in model based systems engineering (pp. 699-712). Cham: Springer International Publishing. https://doi.org/10.1007/978-3-030-82083-1_59
- [11] Zsidisin, G. A., & Ritchie, B. (2008). Supply chain risk: A handbook of assessment, management, and performance. Springer Science & Business Media. https://doi.org/10.1007/978-0-387-79934-6
- [12] Kilic, H. S., Canbakis, S. K., Karabas, M., Koseoglu, S., Unal, E., & Kalender, Z. T. (2023). Integrated supply chain risk assessment methodology based on modified FMEA. Journal of Risk Analysis and Crisis Response, 13(2). 93-116. https://doi.org/10.54560/jracr.v13i2.359
- [13] Tuncel, G., & Alpan, G. (2010). Risk assessment and management for supply chain networks: A case study. Computers in Industry, 61(3), 250–259. https://doi.org/10.1016/j.compind.2009.09.008
- [14] Alsaidalani, R., & Elmadhounb, B. (2021). Quality risk management in pharmaceutical supply chain, warehousing and dispensing-practical case study from sterile pharmaceutical industry. International Journal of Pharmaceutical Sciences Review and Research, 68(2),10. https://doi.org/10.47583/ijpsrr.2021.v68i02.023
- [15] Aqlan, F., & Lam, S. S. (2015). A fuzzy-based integrated framework for supply chain risk assessment. International Journal of Production Economics, 161, 54–63. https://doi.org/10.1016/j.ijpe.2014.11.013
- [16] Marhavilas, P. K., Koulouriotis, D. E., & Mitrakas, C. (2011). On the development of a new hybrid risk assessment process using occupational accidents’ data: Application on the greek public electric power provider. Journal of Loss Prevention in the Process Industries, 24(5), 671–687. https://doi.org/10.1016/j.jlp.2011.05.010
- [17] Handayani, D. I. (2018). Risk management of supplier-buyer in procurement of raw materials for improving supply chain performance. Jurnal Manajemen, 22(3), 293–309. https://doi.org/10.24912/jm.v22i3.423
- [18] Sharma, A., Kumar, D., & Arora, N. (2023). Risk assessment for pharmaceutical industry in uncertain environment: An integrated multi-criteria decision-making approach. Decision Making: Applications in Management and Engineering, 6(2), 293–340. https://doi.org/10.31181/dmame622023688
- [19] Yoseph, G. K., & Sunitiyoso, Y. (2025). Navigating supply chain risk in the pharmaceutical industry: A bibliographic mapping and systematic review using global supply chain risk framework. Journal of Global Operations and Strategic Sourcing, 18(4), 670–701. https://doi.org/10.1108/JGOSS-06-2024-0050
- [20] Faizal, K., & Dr. Palaniappan, Pl. k. (2014). Risk assessment and management in supply chain. Global Journals of Research in Engineering, 14(2), 19–30. https://engineeringresearch.org/index.php/GJRE/article/view/1130
- [21] Chu, C. Y., Park, K., & Kremer, G. E. (2020). A global supply chain risk management framework: An application of text-mining to identify region-specific supply chain risks. Advanced Engineering Informatics, 45, 101053. https://doi.org/10.1016/j.aei.2020.101053
- [22] Kara, M. E., & Fırat, S. Ü. (2017). Supply chain risks: Literature review and a new categorization. Beykent Üniversitesi fen ve Mühendislik Bilimleri Dergisi (BUJSE), 10(1), 31-60. https://izlik.org/JA42GW85ND
- [23] Khan, O., & Burnes, B. (2007). Risk and supply chain management: Creating a research agenda. The International Journal of Logistics Management, 18(2), 197–216. https://doi.org/10.1108/09574090710816931
- [24] Punniyamoorthy, M., Thamaraiselvan, N., & Manikandan, L. (2013). Assessment of supply chain risk: Scale development and validation. Benchmarking: An International Journal, 20(1), 79–105. https://doi.org/10.1108/14635771311299506
- [25] Diabat, A., Govindan, K., & Panicker, V. V. (2012). Supply chain risk management and its mitigation in a food industry. International Journal of Production Research, 50(11), 3039–3050. https://doi.org/10.1080/00207543.2011.588619
- [26] Jaberidoost, M., Olfat, L., Hosseini, A., Kebriaeezadeh, A., Abdollahi, M., Alaeddini, M., & Dinarvand, R. (2015). Pharmaceutical supply chain risk assessment in Iran using analytic hierarchy process (AHP) and simple additive weighting (SAW) methods. Journal of Pharmaceutical Policy and Practice, 8(1), 9. https://doi.org/10.1186/s40545-015-0029-3
- [27] Brako, S. A. (2016). Investigating the risks in the pharmaceutical supply chain in Ghana. International Journal of Academic Research in Business and Social Sciences, 6(6), 7–21. https://doi.org/10.6007/IJARBSS/v6-i6/2176
- [28] Enyinda, C. (2017). Modeling enterprise risk management in operations and supply chain: A pharmaceutical firm context. Operations and Supply Chain Management: An International Journal, 11(1), 1–12. https://doi.org/10.31387/oscm0300195
- [29] Moktadir, M. A., Ali, S. M., Mangla, S. K., Sharmy, T. A., Luthra, S., Mishra, N., & Garza-Reyes, J. A. (2018). Decision modeling of risks in pharmaceutical supply chains. Industrial Management & Data Systems, 118(7), 1388–1412. https://doi.org/10.1108/IMDS-10-2017-0465
- [30] Akter, S., Debnath, B., & Bari, A. B. M. M. (2022). A grey decision-making trial and evaluation laboratory approach for evaluating the disruption risk factors in the emergency life-saving drugs supply chains. Healthcare Analytics, 2, 100120. https://doi.org/10.1016/j.health.2022.100120
- [31] Khan, S. A., Gupta, H., Gunasekaran, A., Mubarik, M. S., & Lawal, J. (2023). A hybrid multi-criteria decision-making approach to evaluate interrelationships and impacts of supply chain performance factors on pharmaceutical industry. Journal of Multi-Criteria Decision Analysis, 30(1–2), 62–90. https://doi.org/10.1002/mcda.1800
- [32] Ostadi, B., Gholami Kaldehi, A., & Kargari, M. (2024). Quality risk management in the pharmaceutical industry: Quality risks identification and validation of artificial tears medicinal product. Standard and Quality Management Journal, 14(3), 1–38. (In Persian) https://doi.org/10.22034/jsqm.2025.493426.1627
- [33] Goswami, A., Baveja, A., Ding, X., Melamed, B., & Roberts, F. (2024). An integrated framework for modeling pharmaceutical supply chains with disruptions and risk mitigation. Annals of Operations Research, 1–26. https://doi.org/10.1007/s10479-024-06381-y
- [34] Ciceri, C., Borsani, C., Guida, M., Farinelli, M., & Caniato, F. (2025). Impact pathways: Navigating risks in the pharmaceutical supply chain-a multi-actor perspective. International Journal of Operations & Production Management, 45(13), 53–62. https://doi.org/10.1108/IJOPM-06-2024-0458
- [35] Fernandes, I. X., de Sá-Soares, F., & Tereso, A. (2022). Modelling and analysing product development processes in the textile and clothing industry. International Conference Innovation in Engineering (pp. 220–233). Springer. https://doi.org/10.1007/978-3-031-09360-9_19
- [36] Sangode, P. B. (2024). Developing a framework for the India pharmaceutical supply chain-risks assessment through a FMEA approach. Asia Pacific Journal of Health Management, 19(3), 241–258. https://doi.org/10.24083/apjhm.v19i3.3171
- [37] Shimoni, Y., Srinivasan, V., & von Gruchalla-Wesierski, M. (2015). A risk-based approach to supplier and raw materials management. BioProcess Intl, 13(10), 10–15. https://www.researchgate.net/publication/287260875_A_risk-based_approach_to_supplier_and_raw_materials_management
- [38] Wheeler, J. T. (2011). The effects of vendor and quality control variability in the procurement of raw materials in a bio-pharmaceutical company [Thesis]. http://hdl.handle.net/1721.1/68901
- [39] Wahab, S. N., Ahmed, N., & Ab Talib, M. S. (2024). An overview of the SWOT analysis in India’s pharmaceutical supply chain. Arab Gulf Journal of Scientific Research, 42(3), 771–787. https://doi.org/10.1108/AGJSR-03-2023-0102
- [40] Shah, N. (2004). Pharmaceutical supply chains: Key issues and strategies for optimisation. Computers & Chemical Engineering, 28(6–7), 929–941. https://doi.org/10.1016/j.compchemeng.2003.09.022
- [41] Wong, W. P., Saw, P. S., Jomthanachai, S., Wang, L. S., Ong, H. F., & Lim, C. P. (2023). Digitalization enhancement in the pharmaceutical supply network using a supply chain risk management approach. Scientific Reports, 13(1), 22287. https://doi.org/10.1038/s41598-023-49606-z
- [42] Pariazar, M., Root, S., & Sir, M. Y. (2017). Supply chain design considering correlated failures and inspection in pharmaceutical and food supply chains. Computers & Industrial Engineering, 111, 123–138. https://doi.org/10.1016/j.cie.2017.07.009
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