Pharmaceutical Expansion: Contractor Coordination and Risk Management

Abstract

This study analyzes the execution of a pharmaceutical granulation facility expansion project conducted within an active manufacturing environment. The project aimed to increase production capacity, optimize process flow, and improve material handling while maintaining compliance with Good Manufacturing Practices. Due to the involvement of multiple contractors and critical operational constraints, safety management and coordination were identified as key challenges. Using Define, Measure, Analyze, Improve, Control methodology and Root Cause Analysis, safety observations were evaluated to identify recurring risk patterns, high-risk activities, and root causes. Results indicated that improper use of personal protective equipment, unsafe handling of mobile equipment, and risks associated with working at heights were the most frequent and severe issues. Based on these findings, targeted improvement strategies were developed, including enhanced supervision, stricter safety controls, and improved contractor coordination. The study provides practical recommendations to strengthen safety performance and support more efficient execution of similar industrial projects.