Risk-Based Evaluation of Pharmaceutical Tablet Defects Using Failure Mode and Effects Analysis Before and After Process Improvement
DOI:
10.29303/jppipa.v12i10.16302Published:
2026-10-06Downloads
Abstract
This study assessed pharmaceutical tablet-manufacturing risk before and after a coordinated process-improvement programme using Failure Mode and Effects Analysis (FMEA). It focused on identifying and ranking failure modes, comparing their Risk Priority Numbers (RPNs), and quantifying residual risk reduction for the AL-MAG 1050 mg tablet line at Alben Healthcare Industries Limited, Nigeria. A retrospective before-and-after industrial risk-evaluation design examined 100 production-batch and quality records from 2022 to 2024. Eight baseline FMEA entries were screened, with four matched failure modes retained: capping, lamination, moisture drift and tool wear. The intervention tightened granule-moisture, blending-time, compression-speed and compression-force windows alongside revised Standard Operating Procedures, process monitoring and tooling controls. Risk reduction was evaluated descriptively using paired RPNs, absolute change, percentage reduction and residual ranking. Capping (50.10%) and lamination (23.57%) dominated the baseline defect burden. Post-intervention RPNs decreased from 280 to 120, 240 to 110, 210 to 95 and 190 to 90, respectively. Reductions ranged from 52.63% to 57.14%, while the aggregate descriptive RPN index declined by 54.89%, from 920 to 415. Despite these improvements, the ranking remained unchanged, with capping retaining the highest residual priority. The findings support continued risk-based surveillance of compression-related failure mechanisms
Keywords:
Failure Mode and Effects Analysis (FMEA) Pharmaceutical Tablet Manufacturing Process Improvement Residual Risk Risk Priority Number (RPN)References
Alsaidalani, R., & Elmadhoun, B. (2022). Quality risk management in pharmaceutical manufacturing operations: Case study for sterile product filling and final product handling stage. Sustainability, 14(15), 9618. https://doi.org/10.3390/su14159618
Bekaert, B., Janssen, P. H. M., Fathollahi, S., Vanderroost, D., Roelofs, T. P., Dickhoff, B. H. J., Vervaet, C., & Vanhoorne, V. (2024). Batch vs. continuous direct compression: A comparison of material processability and final tablet quality. International Journal of Pharmaceutics: X, 7, 100226. https://doi.org/10.1016/j.ijpx.2023.100226
Elmadhoun, B., Alsaidalani, R., & Burczynski, F. (2025). Quality risk management in the final operational stage of sterile pharmaceutical manufacturing: A case study highlighting the management of sustainable related risks in product sterilization, inspection, labeling, packaging, and storage processes. Sustainability, 17(4), 1670. https://doi.org/10.3390/su17041670
Gül, M., Yucesan, M., & Çelik, E. (2020). A manufacturing failure mode and effect analysis based on fuzzy and probabilistic risk analysis. Applied Soft Computing, 96, 106689. https://doi.org/10.1016/j.asoc.2020.106689
Huang, J., You, J.-X., Liu, H.-C., & Song, M.-S. (2020). Failure mode and effect analysis improvement: A systematic literature review and future research agenda. Reliability Engineering & System Safety, 199, 106885. https://doi.org/10.1016/j.ress.2020.106885
International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use. (2023). ICH Q9(R1): Quality risk management.
Kendrick, B. S., Gabrielson, J. P., Hunt, D., Christie, M., Bowen, S., Vessely, C., et al. (2024). Quality risk management and data integrity in R&D laboratories supporting CMC lifecycle of biological products. Journal of Pharmaceutical Sciences, 113(11), 3123–3136. https://doi.org/10.1016/j.xphs.2024.09.013
Kim, J.-E., & Park, Y.-J. (2022). QbD consideration for developing a double-layered tablet into a single-layered tablet with telmisartan and amlodipine. Pharmaceutics, 14(2), 377. https://doi.org/10.3390/pharmaceutics14020377
Liu, H.-C., Zhang, L.-J., Ping, Y.-J., & Wang, L. (2020). Failure mode and effects analysis for proactive healthcare risk evaluation: A systematic literature review. Journal of Evaluation in Clinical Practice, 26(4), 1320–1337. https://doi.org/10.1111/jep.13317
Lyytikäinen, J., Stasiak, P., Kubelka, T., Olenius, T., Korhonen, O., Ketolainen, J., & Ervasti, T. (2022). Parameter optimization in a continuous direct compression process of commercially batch-produced bisoprolol tablets. International Journal of Pharmaceutics, 628, 122355. https://doi.org/10.1016/j.ijpharm.2022.122355
Nwamekwe, C. O., Edokpia, R. O., & Eboigbe, C. I. (2026). Integration of machine learning into Lean Six Sigma: A systematic review for enhancing predictive analytics in the pharmaceutical industry. Siber Journal of Advanced Multidisciplinary, 3(4), 133–151. https://doi.org/10.38035/sjam.v3i4.638
Nwamekwe, C. O., Edokpia, R. O., & Igbinosa, E. C. (2025b). Exploring the role of artificial intelligence in enhancing lean manufacturing and Six Sigma for smart factories. International Journal of Industrial Engineering, Technology and Operations Management, 3(1), 1–12. https://doi.org/10.62157/ijietom.v3i1.61
Nwamekwe, C. O., Ewuzie, N. V., Okpala, C. C., Ezeanyim, O. C., Nwabueze, C. V., & Nwabunwanne, E. C. (2025a). Optimizing machine learning models for soil fertility analysis: Insights from feature engineering and data localization. Gazi University Journal of Science Part A: Engineering and Innovation, 12(1), 36–60.
Ohsaki, S., Kushida, K., Matsuda, Y., Nakamura, H., & Watano, S. (2020). Numerical study for tableting process in consideration of compression speed. International Journal of Pharmaceutics, 575, 118936. https://doi.org/10.1016/j.ijpharm.2019.118936
Patel, V. D., Patel, D. B., Sturgis, J. C., Queensen, K., Sedlock, R., & Haware, R. V. (2023). Assessing the impact of punch geometries on tablet capping using a newly proposed capping index. Pharmaceutical Research, 40(12), 2935–2945. https://doi.org/10.1007/s11095-023-03555-4
Peddapatla, R. V. G., Sheridan, G., Slevin, C., Swaminathan, S., et al. (2021). Process model approach to predict tablet weight variability for direct compression formulations at pilot and production scale. Pharmaceutics, 13(7), 1033. https://doi.org/10.3390/pharmaceutics13071033
Poli, M., Quaglierini, M., Zega, A., Pardini, S., Telleschi, M., Iervasi, G., & Guiducci, L. (2024). Risk management in Good Manufacturing Practice (GMP) radiopharmaceutical preparations. Applied Sciences, 14(4), 1584. https://doi.org/10.3390/app14041584
World Health Organization. (2024). Quality assurance of pharmaceuticals: A compendium of guidelines and related materials: Vol. 2. Good manufacturing practices and inspection (10th ed.).
Yang, S., Hu, X.-M., Zhu, J., et al. (2025). Aspects and implementation of pharmaceutical Quality by Design from conceptual frameworks to industrial applications. Pharmaceutics, 17(5), 623. https://doi.org/10.3390/pharmaceutics17050623
Zheng, H., & Tang, Y. (2020). Deng entropy weighted Risk Priority Number model for Failure Mode and Effects Analysis. Entropy, 22(3), 280. https://doi.org/10.3390/e22030280
License
Copyright (c) 2026 Charles Onyeka Nwamekwe, Raphael Olumese Edokpia
This work is licensed under a Creative Commons Attribution 4.0 International License.
Authors who publish with Jurnal Penelitian Pendidikan IPA, agree to the following terms:
- Authors retain copyright and grant the journal right of first publication with the work simultaneously licensed under a Creative Commons Attribution 4.0 International License (CC-BY License). This license allows authors to use all articles, data sets, graphics, and appendices in data mining applications, search engines, web sites, blogs, and other platforms by providing an appropriate reference. The journal allows the author(s) to hold the copyright without restrictions and will retain publishing rights without restrictions.
- Authors are able to enter into separate, additional contractual arrangements for the non-exclusive distribution of the journal's published version of the work (e.g., post it to an institutional repository or publish it in a book), with an acknowledgment of its initial publication in Jurnal Penelitian Pendidikan IPA.
- Authors are permitted and encouraged to post their work online (e.g., in institutional repositories or on their website) prior to and during the submission process, as it can lead to productive exchanges, as well as earlier and greater citation of published work (See The Effect of Open Access).
