LIFE SCIENCES
Delivering complex pharmaceutical projects on time and in compliance
A leading pharmaceutical company and key player in diabetes treatment, required support to manage engineering and Commissioning & Qualification (C&Q) activities during production shutdowns. The objective was to coordinate internal and external resources while ensuring compliance and maintaining project timelines during revamping and installation activities.
The challenge
The project involved the coordination of complex shutdown activities, including engineering interventions, installation of new equipment, and validation tasks within a constrained timeframe.
Key challenges included:
- Managing internal and external resources during shutdown periods
- Ensuring alignment between engineering, C&Q, and supplier activities
- Maintaining control over timelines and workplans in a high-pressure environment
- Handling discrepancies and deviations identified during testing
Minimising delays and ensuring compliance with GMP and client procedures
The solution
ALTEN provided dedicated project management support to plan, coordinate, and monitor all shutdown-related activities. The scope of activities included:
- Planning and coordinating internal and external resources
- Establishing project baselines covering resources, budgets, milestones, stakeholder engagement, and risk management plans, with continuous monitoring of key risks and mitigation actions throughout execution
- Analysing engineering activities (revamping, installation of new equipment)
- Developing verification strategies and test plans
- Executing C&Q testing activities
- Investigating discrepancies through root cause analysis
- Monitoring all activities (engineering, suppliers, testing), project costs, timelines, and risks, while adapting plans proactively to address delays, issues, and deviations
The project relied on standard tools and frameworks such as GMP practices, client procedures, Microsoft Project, and Veeva Vault Quality, ensuring structured execution and traceability.
Results & benefits
ALTEN’s structured approach enabled effective control of shutdown activities and project execution. This resulted in:
- Execution of C&Q activities without significant delays
- Overall shutdown deadlines maintained, with only slight or no delays
- 100% closure of discrepancies within deadlines
- Balanced management of workload and overtime across resources
Key project takeaways
This project demonstrates the importance of strong project management in coordinating complex engineering and validation activities during critical shutdown periods. Through structured planning, continuous monitoring, and effective management of discrepancies and resources, ALTEN ensured controlled execution, maintained timelines, and supported compliant project delivery in a demanding industrial environment.
