Aligning Value Stream Mapping with Current Good Manufacturing Practice (cGMP) Requirements in Pharmaceutical Production Environments

Abstract

The pharmaceutical industry operates under tight controls of current Good Manufacturing Practice (cGMP). The application of lean principles under such circumstances often becomes more complicated than may appear at first glance. In this study, a lean compliancefocused Value Stream Mapping approach was designed and implemented with the aim of ensuring process improvement while maintaining regulatory compliance. Based on the results of a single-case study of the State Company for Drug Industries Samarra suspension line, the pre- and post-implementation performance was measured using operational KPIs, compliance metrics, process mapping and internal audit results. Compliance-oriented lean interventions included introduction of checkpoints according to cGMP regulations, setup reduction, queue management, digital support for batch record, and quality-assurance batch release process logic. As a result of intervention, lead time decreased by 28.2%, throughput increased by 29.3%, Overall Equipment Effectiveness was improved by 19.7% and defect rate dropped by 34.4%. At the same time, the time required to obtain batch release from quality assurance, close deviations and documentation errors were also reduced significantly. This study demonstrates that compliance activities do not have to be considered wasteful in the context of lean improvement projects.

Article history: Received (January 26, 2026); Revised (April 23, 2026); Accepted (June 7, 2026); Published online (October 5, 2026)