From Risk to Control: Mastering Contamination in Pharma

Contamination represents a critical challenge in pharmaceutical manufacturing, with direct implications for product quality, patient safety, and regulatory compliance. To address these risks effectively, it is essential for organizations to define and implement robust contamination control strategies grounded in the principles of risk management. These strategies must not only be comprehensive and well-documented, but also dynamic—subject to regular review and adaptation in light of process knowledge, operational experience, and emerging scientific understanding. Continuous improvement, driven by data and cross-functional collaboration, is key to ensuring that contamination risks are anticipated, mitigated, and controlled throughout the product lifecycle. 

The 2025 edition of iRACI aims to provide a focused and practical overview of how to identify, assess, and effectively control these risks across the manufacturing environment. From facility design and equipment qualification to personnel behaviour and environmental monitoring, we will explore the key elements that form a robust contamination control strategy under GMP guidelines.