Emirati Journal of Business, Economics, & Social Studies

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Vol. 4 No. 1 (2025): Emirati Journal of Business, Economics and Social Studies

The Impact of Multiple Production Lines on the Effectiveness of Quality Management Systems and Internal Controls in Pharmaceutical Manufacturing

  • Bayan Rihawi
Submitted
May 7, 2025
Published
2025-06-06

Abstract

Pharmaceutical manufacturing is one of the most highly regulated industries globally due to its direct influence on patient safety and public health. To meet increasing market demand, many pharmaceutical firms operate multiple production lines, each potentially dedicated to a different product category—such as oral tablets, sterile injectables, or topical creams. While this strategy enhances productivity and flexibility, it introduces significant challenges in maintaining effective Quality Management Systems (QMS) and internal controls (Kechagias et al., 2021). The International Council for Harmonization (ICH Q10) emphasizes the importance of a robust pharmaceutical quality system that spans the product lifecycle. However, the complexity of coordinating several production lines can strain systems for batch release, deviation management, validation, and documentation (EMA, 2020). This study explores how such operational complexity affects the integrity and performance of QMS and internal control frameworks in pharmaceutical plants.

References

  1. Banerjee, S., Roy, A., & Gupta, M. (2021). Ensuring quality consistency in pharmaceutical manufacturing. International Journal of Pharmaceutical Sciences Review and Research, 70(2), 54–61.
  2. Bernasconi, C., Ricci, A., & Fontana, P. (2023). Quality maturity models in pharmaceutical operations: A roadmap for excellence. Journal of Regulatory Science, 11(1), 45–57.
  3. Chen, Y., Liu, T., & Zhao, X. (2023). Real-time quality monitoring using MES in pharmaceutical production. Computers & Industrial Engineering, 180, 109209. https://doi.org/10.1016/j.cie.2023.109209
  4. EMA. (2020). EMA reflection paper on a pharmaceutical quality system. European Medicines Agency. https://www.ema.europa.eu
  5. FDA. (2022). Guidance for Industry: Quality Systems Approach to Pharmaceutical CGMP Regulations. U.S. Food and Drug Administration. https://www.fda.gov
  6. FDA. (2023). Risk Management Plans for Multi-Line Facilities. U.S. Food and Drug Administration. https://www.fda.gov
  7. Gonzalez, M., & Martin, A. (2022). Comparative study of CAPA efficiency before and after QMS digitalization. Pharmaceutical Engineering, 42(5), 45–53.
  8. ICH Q10. (2022). Pharmaceutical Quality System. International Council for Harmonisation. https://www.ich.org
  9. Kechagias, G., Papadopoulos, T., & Georgiadis, P. (2021). Operational risks in multi-line pharmaceutical production. Operations and Supply Chain Management, 14(3), 289–298.
  10. Kumar, S., & Nair, V. (2018). Challenges in managing pharmaceutical production complexity: A QMS perspective. Quality Management in Health Care, 27(1), 20–28.
  11. KPMG. (2021). Digital Quality Transformation in Life Sciences. KPMG Global Life Sciences Report. https://home.kpmg
  12. Lee, J. H., Kim, S. J., & Park, H. (2020). Digital transformation of pharmaceutical quality systems. Computers in Biology and Medicine, 124, 103918. https://doi.org/10.1016/j.compbiomed.2020.103918
  13. Müller, L., & Meissner, A. (2020). Cross-functional quality risk management in multi-line production systems. International Journal of Production Economics, 229, 107758.
  14. Sandle, T. (2022). Lean manufacturing and quality integration in pharmaceutical plants. Pharmaceutical Technology Europe, 34(7), 24–30.
  15. Singh, R., Sharma, D., & Jain, V. (2021). Impact of multiple production lines on GMP compliance in pharmaceutical manufacturing. Journal of Pharmaceutical Quality, 34(3), 122–130. https://doi.org/10.1016/j.jphq.2021.02.003
  16. WHO. (2023). Good Manufacturing Practices for Pharmaceutical Products: WHO Technical Report Series No. 1030. World Health Organization. https://www.who.int

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