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Updated Review on Risk Management Strategies in Quality Assurance for the Pharmaceutical Industry
Corresponding Author(s) : Dima Akram Ibrahim
International Journal of Allied Medical Sciences and Clinical Research,
Vol. 13 No. 2 (2025): 2025 Volume -13 - Issue 2
Abstract
Quality assurance risk management (QRM) is a critical component of the pharmaceutical industry that is performed to ensure the product and process safety and regulatory compliance. This review presents the significance of risk assessment and its control strategies, supported with examples from past incidents (eg, heparin contamination crisis, product recalls) supporting the need for sound risk management practices. Specifically, GMP guidelines are in place to ensure that pharmaceutical companies adhere to correct quality standards to prevent the hindrance of manufacturing authorizations and marketing approvals for qualified companies. This review highlights risk assessment tools and methodologies that inform hazard/risks identification and mitigation and summarizes the regulatory landscape informing risk management. International Council for Harmonisation (ICH) has played a significant role in this area with the Q9 and Q10 guidelines that encourage a systematic, science-based approach to risk management across the product lifecycle from development through distribution. Adhering to these standards is not just critical for meeting regulatory requirements but also for upholding industry credibility and consumer confidence. The scope of these measures guarantees the quality of their products and, thus, improves public health. This review details the state-of-the-art and future aspects of pharmaceutical quality risk management, highlighting the requirements of regulatory standards. Ultimately, the establishment of sound risk management practices not only enhances the safety, efficacy, and reliability of pharmaceutical products but also helps regain the trust in the industry.
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- Abbasian, H., Zenouz, R. Y., Abdollahiasl, A., Toroski, M., Nikfar, S., Siahi‐Shadbad, M., & Kebriaeezadeh, A. (2020). Risk Factors of Supply Chain in Biopharmaceutical Companies in Iran. In Pharmaceutical Sciences (Vol. 27, Issue 3, p. 439). Tabriz University of Medical Sciences. https://doi.org/10.34172/ps.2020.93.
- Bucalo, N., & Jereb, B. (2017). Risk Management in the Pharmaceutical Industry in Slovenian Companies. In Logistics Supply Chain Sustainability and Global Challenges (Vol. 8, Issue 1, p. 42). De Gruyter Open. https://doi.org/10.1515/jlst-2017-0004.
- Calvo, J., Olmo, J. L. D., & Silvente, V. B. (2020). Supply chain resilience and agility: a theoretical literature review. In International Journal of Supply Chain and Operations Resilience (Vol. 4, Issue 1, p. 37). https://doi.org/10.1504/ijscor.2020.105950.
- Güngör, D. Ö., Sharma, M., Dhir, A., & Daim, T. (2022). Supply chain resilience during the COVID-19 pandemic. In Technology in Society (Vol. 68, p. 101847). Elsevier BV. https://doi.org/10.1016/j.techsoc.2021.101847.
- Korčok, D., Tršić-Milanović, N., Mitić, B., & Karadžić, N. (2020). The importance of integrated management systems in pharmacy. In Tehnika (Vol. 75, Issue 1, p. 120). Savez inženjera i tehničara Srbije. https://doi.org/10.5937/tehnika2001120k.
- Mensah, P., & Merkuryev, Y. (2014). Developing a Resilient Supply Chain. In Procedia - Social and Behavioral Sciences (Vol. 110, p. 309). Elsevier BV. https://doi.org/10.1016/j.sbspro.2013.12.875.
- Montoya, G. N., Santos, J. B. S., Novaes, A. G., & Lima, O. F. (2018). Internet of Things and the Risk Management Approach in the Pharmaceutical Supply Chain. In Lecture notes in logistics (p. 284). Springer Nature. https://doi.org/10.1007/978-3-319-74225-0_38.
- Patel, J. D. (2017). Drug Approval Regulation: The Global Impacts. In Journal of Bacteriology & Mycology Open Access (Vol. 4, Issue 6). MedCrave Group. https://doi.org/10.15406/jbmoa.2017.04.00113.
- Reis, C. P., Gouveia, B., Rijo, P., & Gonçalo, T. (2015). Good manufacturing practices for medicinal products for human use [Review of Good manufacturing practices for medicinal products for human use]. Journal of Pharmacy And Bioallied Sciences, 7(2), 87. Medknow. https://doi.org/10.4103/0975-7406.154424.
- Riad, M., Naïmi, M., & Okar, C. (2024). Enhancing Supply Chain Resilience Through Artificial Intelligence: Developing a Comprehensive Conceptual Framework for AI Implementation and Supply Chain Optimization. In Logistics (Vol. 8, Issue 4, p. 111). Multidisciplinary Digital Publishing Institute. https://doi.org/10.3390/logistics8040111.
- Riyadh, M. (2024). Transforming the Shipping Industry with Autonomous Ships and Artificial Intelligence. In Maritime Park Journal of Maritime Technology and Society (p. 16). https://doi.org/10.62012/mp.v3i2.35386.
- Sharma, D. K., Bhargava, S., & Singhal, K. (2020). Internet of Things applications in the pharmaceutical industry. In Elsevier eBooks (p. 153). Elsevier BV. https://doi.org/10.1016/b978-0-12-821326-1.00006-1.
- Suwandi, A., Zagloel, T. Y. M., & Hidayatno, A. (2018). Conceptual model of failure risk control on raw materials inventory system. In IOP Conference Series Materials Science and Engineering (Vol. 453, p. 12007). IOP Publishing. https://doi.org/10.1088/1757-899x/453/1/012007.
- Tang, O., & Musa, S. N. (2010). Identifying risk issues and research advancements in supply chain risk management. In International Journal of Production Economics (Vol. 133, Issue 1, p. 25). Elsevier BV. https://doi.org/10.1016/j.ijpe.2010.06.013.
- Tummala, R., & Schoenherr, T. (2011). Assessing and managing risks using the Supply Chain Risk Management Process (SCRMP). In Supply Chain Management An International Journal (Vol. 16, Issue 6, p. 474). Emerald Publishing Limited. https://doi.org/10.1108/13598541111171165.
- Uchechukwu, J. (2024). Advancing sustainability and efficiency in maritime operations: Integrating green technologies and autonomous systems in global shipping. In International Journal of Science and Research Archive (Vol. 13, Issue 2, p. 2059). https://doi.org/10.30574/ijsra.2024.13.2.2419.
- Urbaniak, M., Zimon, D., Madzík, P., & Šírová, E. (2022). Risk factors in the assessment of suppliers. In PLoS ONE (Vol. 17, Issue 8). Public Library of Science. https://doi.org/10.1371/journal.pone.0272157.
- Waqas, U., Rahman, A. A., Ismail, N. W., Basha, N. K., & Umair, S. (2022). Influence of supply chain risk management and its mediating role on supply chain performance: perspectives from an agri-fresh produce. In Annals of Operations Research (Vol. 324, p. 1399). Springer Science+Business Media. https://doi.org/10.1007/s10479-022-04702-7.
- Xu, Z. (2022). Considerations on Regulatory Quality Control in Pharmaceutical Industry. In Advances in economics, business and management research/Advances in Economics, Business and Management Research. Atlantis Press. https://doi.org/10.2991/aebmr.k.220306.047.
- Zsidisin, G. A., Ellram, L. M., Carter, J. R., & Cavinato, J. L. (2004). An analysis of supply risk assessment techniques. In International Journal of Physical Distribution & Logistics Management (Vol. 34, Issue 5, p. 397). Emerald Publishing Limited. https://doi.org/10.1108/09600030410545445.
References
Abbasian, H., Zenouz, R. Y., Abdollahiasl, A., Toroski, M., Nikfar, S., Siahi‐Shadbad, M., & Kebriaeezadeh, A. (2020). Risk Factors of Supply Chain in Biopharmaceutical Companies in Iran. In Pharmaceutical Sciences (Vol. 27, Issue 3, p. 439). Tabriz University of Medical Sciences. https://doi.org/10.34172/ps.2020.93.
Bucalo, N., & Jereb, B. (2017). Risk Management in the Pharmaceutical Industry in Slovenian Companies. In Logistics Supply Chain Sustainability and Global Challenges (Vol. 8, Issue 1, p. 42). De Gruyter Open. https://doi.org/10.1515/jlst-2017-0004.
Calvo, J., Olmo, J. L. D., & Silvente, V. B. (2020). Supply chain resilience and agility: a theoretical literature review. In International Journal of Supply Chain and Operations Resilience (Vol. 4, Issue 1, p. 37). https://doi.org/10.1504/ijscor.2020.105950.
Güngör, D. Ö., Sharma, M., Dhir, A., & Daim, T. (2022). Supply chain resilience during the COVID-19 pandemic. In Technology in Society (Vol. 68, p. 101847). Elsevier BV. https://doi.org/10.1016/j.techsoc.2021.101847.
Korčok, D., Tršić-Milanović, N., Mitić, B., & Karadžić, N. (2020). The importance of integrated management systems in pharmacy. In Tehnika (Vol. 75, Issue 1, p. 120). Savez inženjera i tehničara Srbije. https://doi.org/10.5937/tehnika2001120k.
Mensah, P., & Merkuryev, Y. (2014). Developing a Resilient Supply Chain. In Procedia - Social and Behavioral Sciences (Vol. 110, p. 309). Elsevier BV. https://doi.org/10.1016/j.sbspro.2013.12.875.
Montoya, G. N., Santos, J. B. S., Novaes, A. G., & Lima, O. F. (2018). Internet of Things and the Risk Management Approach in the Pharmaceutical Supply Chain. In Lecture notes in logistics (p. 284). Springer Nature. https://doi.org/10.1007/978-3-319-74225-0_38.
Patel, J. D. (2017). Drug Approval Regulation: The Global Impacts. In Journal of Bacteriology & Mycology Open Access (Vol. 4, Issue 6). MedCrave Group. https://doi.org/10.15406/jbmoa.2017.04.00113.
Reis, C. P., Gouveia, B., Rijo, P., & Gonçalo, T. (2015). Good manufacturing practices for medicinal products for human use [Review of Good manufacturing practices for medicinal products for human use]. Journal of Pharmacy And Bioallied Sciences, 7(2), 87. Medknow. https://doi.org/10.4103/0975-7406.154424.
Riad, M., Naïmi, M., & Okar, C. (2024). Enhancing Supply Chain Resilience Through Artificial Intelligence: Developing a Comprehensive Conceptual Framework for AI Implementation and Supply Chain Optimization. In Logistics (Vol. 8, Issue 4, p. 111). Multidisciplinary Digital Publishing Institute. https://doi.org/10.3390/logistics8040111.
Riyadh, M. (2024). Transforming the Shipping Industry with Autonomous Ships and Artificial Intelligence. In Maritime Park Journal of Maritime Technology and Society (p. 16). https://doi.org/10.62012/mp.v3i2.35386.
Sharma, D. K., Bhargava, S., & Singhal, K. (2020). Internet of Things applications in the pharmaceutical industry. In Elsevier eBooks (p. 153). Elsevier BV. https://doi.org/10.1016/b978-0-12-821326-1.00006-1.
Suwandi, A., Zagloel, T. Y. M., & Hidayatno, A. (2018). Conceptual model of failure risk control on raw materials inventory system. In IOP Conference Series Materials Science and Engineering (Vol. 453, p. 12007). IOP Publishing. https://doi.org/10.1088/1757-899x/453/1/012007.
Tang, O., & Musa, S. N. (2010). Identifying risk issues and research advancements in supply chain risk management. In International Journal of Production Economics (Vol. 133, Issue 1, p. 25). Elsevier BV. https://doi.org/10.1016/j.ijpe.2010.06.013.
Tummala, R., & Schoenherr, T. (2011). Assessing and managing risks using the Supply Chain Risk Management Process (SCRMP). In Supply Chain Management An International Journal (Vol. 16, Issue 6, p. 474). Emerald Publishing Limited. https://doi.org/10.1108/13598541111171165.
Uchechukwu, J. (2024). Advancing sustainability and efficiency in maritime operations: Integrating green technologies and autonomous systems in global shipping. In International Journal of Science and Research Archive (Vol. 13, Issue 2, p. 2059). https://doi.org/10.30574/ijsra.2024.13.2.2419.
Urbaniak, M., Zimon, D., Madzík, P., & Šírová, E. (2022). Risk factors in the assessment of suppliers. In PLoS ONE (Vol. 17, Issue 8). Public Library of Science. https://doi.org/10.1371/journal.pone.0272157.
Waqas, U., Rahman, A. A., Ismail, N. W., Basha, N. K., & Umair, S. (2022). Influence of supply chain risk management and its mediating role on supply chain performance: perspectives from an agri-fresh produce. In Annals of Operations Research (Vol. 324, p. 1399). Springer Science+Business Media. https://doi.org/10.1007/s10479-022-04702-7.
Xu, Z. (2022). Considerations on Regulatory Quality Control in Pharmaceutical Industry. In Advances in economics, business and management research/Advances in Economics, Business and Management Research. Atlantis Press. https://doi.org/10.2991/aebmr.k.220306.047.
Zsidisin, G. A., Ellram, L. M., Carter, J. R., & Cavinato, J. L. (2004). An analysis of supply risk assessment techniques. In International Journal of Physical Distribution & Logistics Management (Vol. 34, Issue 5, p. 397). Emerald Publishing Limited. https://doi.org/10.1108/09600030410545445.