Achieving operational excellence in a Contract Development and Manufacturing Organization (CDMO) is crucial to ensure the quality and consistency of products and services. This can be achieved by implementing robust controls, optimizing workflows, and fostering a culture of continuous improvement. Here are some key strategies to achieve operational excellence in a CDMO:
Table of Contents
Implementing Robust Controls
Compliance with Regulatory Guidelines: Ensure compliance with strict regulatory standards set by global authorities such as the U.S. Food and Drug Administration (FDA), European Medicines Agency (EMA), and Japan’s Pharmaceuticals and Medical Devices Agency (PMDA).
Quality by Design (QbD) Principles: Embrace QbD principles to create robust and scalable manufacturing processes that prioritize product quality and performance attributes. This includes employing risk-based approaches and process analytical technologies (PAT) to optimize process parameters and enhance product consistency.
Validation & Qualifications Protocols: Perform validation studies and qualification assessments to ensure the reliability and reproducibility of manufacturing processes. This includes analytical testing, in-process monitoring, and validation protocols to assess product attributes and detect deviations.
Optimizing Workflows
Process Centric Teams: Form Process Centric Teams (PCTs) that are empowered to define goals and set targets. These teams should be guided by a standardized work approach and a balanced scorecard to measure and monitor performance.
Standardizing Work: Standardize work and define the “one” best way of organizing operations for safety, efficiency, productivity, and quality. This includes integrating processes and teams to drive higher performance and installing an integrated system for continuous improvement.
Lean Operational Excellence: Implement lean operational excellence principles to eliminate waste, maximize utilization of equipment and personnel, and improve productivity, quality, and speed of services.
Fostering a Culture of Continuous Improvement
Employee Empowerment: Create a culture of respect, empowerment, and continuous improvement among employees. This can be achieved by providing ongoing training and development programs to enhance their skills and knowledge.
Cohesive Management and Leadership: Align vision, strategy, goals, and metrics across all levels and functions of the organization. This can be achieved through systems such as tiered daily huddles, leadership development, and leader standard work.
Continuous Improvement Toolbox: Provide a continuous improvement toolbox to identify sources of opportunity or loss and drive quality and performance indicators. This includes tools such as root-cause problem solving and deep process understanding.
Partnering for Success
Strategic Partnerships: Establish strategic partnerships with biotech and biopharma companies to understand their specific goals, timelines, and regulatory requirements. This includes providing manufacturing services for complex biopharmaceuticals and leveraging expertise in bioprocessing technologies.
Supply Chain Management & Risk Mitigation: Implement robust supply chain strategies to minimize supply chain disruption and maintain product integrity throughout the manufacturing process. This includes establishing strategic partnerships with reliable suppliers and implementing strict quality control measures.
Conclusion
Achieving operational excellence in a CDMO requires a multifaceted approach that includes implementing robust controls, optimizing workflows, fostering a culture of continuous improvement, and partnering for success. By adopting these strategies, CDMOs can ensure the quality and consistency of their products and services, ultimately benefiting their clients and patients.
“Operational Excellence is an approach to organizational improvement that focuses on meeting customer needs. It is a new way of working that is based on teamwork and employee empowerment that involves eliminating all types of waste from business operations.” – Servier CDMO
References:
- Pfizer CentreOne. (n.d.). Manufacturing Excellence is a Team Effort. Retrieved from https://www.pfizercentreone.com/insights-resources/articles/manufacturing-excellence-team-effort
- Woods. (2023, May 18). Bring Excellence to your CDMO: Top 10 ways Operational Excellence can enhance your business. LinkedIn. Retrieved from https://www.linkedin.com/pulse/bring-excellence-your-cdmo-top-10-benefits-ways-can-enhance-woods
- Reynolds. (2023, August 1). Lean & Operational Excellence in Life Science CDMO’s. LinkedIn. Retrieved from https://www.linkedin.com/pulse/lean-operational-excellence-life-science-cdmos-tom-reynolds
- GBI Bio. (2024, February 29). Overcoming Scalability in Biologics: CDMO Strategies for Success. Retrieved from https://www.gbibio.com/overcoming-scalability-in-biologics-cdmo-strategies-for-success/
- Pharmasalmanac. (2018, March 29). Transforming A CDMO Using an Operational Excellence Approach. Retrieved from https://www.pharmasalmanac.com/articles/transforming-a-cdmo-using-an-operational-excellence-approach
