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

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.