7
Manufacturing sites
Ensuring Compliance at a Nutritional Health Manufacturer
Industry: Life Sciences
Service: Manufacturing
Service: Operations Strategy and Transformation
Service: Transactions and Turnaround
Our Client
A global leader in the development, manufacturing, and commercialization of science-based nutritional health products faced critical process and infrastructure flaws at one of its European factories.
13
brands
1.3K
Employees worldwide
The Challenge
The company was struggling to maintain compliance with internal corporate and public administration standards. At the same time, rising customer demand exposed additional weaknesses in production and packaging operations, leading to frequent production stoppages.
The urgency of these issues escalated as the company’s controlling private equity firm prepared for an imminent sale to a major industrial conglomerate, making the mitigation of compliance risks a prerequisite for the transaction. Key challenges included:
- Obsolete ventilation systems, preventing compliance with air flow and cleaning regulations.
- Ineffective emergency response procedures, creating health, safety, and operational risks.
- Explosion risk due to inadequate infrastructure and monitoring.
- 60 deviations from Good Manufacturing Practices (GMP) identified by a public health & safety audit, threatening production continuity.
- Limited resources and lack of proactive decision-making, with projects running parallel to other ongoing initiatives.
Real Results Achieved Together
In collaboration with EFESO, the global nutritional health manufacturer eliminated all 60 GMP compliance violations and critical safety risks, enabling successful company sale.
60
Good Manufacturing Practices (GMP) deviations addressed
24/7
Operational emergency response measures implemented to safeguard employee well-being
Transformation Impact
- Identified regulatory barriers preventing further upgrades to the obsolete ventilation system.
- Conducted a comprehensive safety audit of infrastructure and procedures.
- Strengthened Health, Safety, and Emergency (HSE) policies and procedures.
Our Approach
EFESO collaborated with global and local operations teams to rapidly address compliance risks through four simultaneous workstreams:
Ventilation System Compliance
- Developed a replacement strategy to meet compliance requirements and ensure proper air flow and cleaning.
Emergency Response & Safety Procedures
- Strengthened Health, Safety, and Emergency (HSE) policies and procedures.
Explosion Risk Mitigation
- Designed and implemented risk monitoring and compliance protocols.
GMP Compliance & Audit Resolution
- Developed a structured plan to resolve non-compliance issues within six months, ensuring production continuity.
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Facing Similar Challenges?
- Ensure collaboration between global and local operations teams to rapidly address compliance risks.
- Mitigate compliance risks and ineffective emergency response procedures.
- Engage rising customer demand and reduce production stoppages.
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