Impurity Control Strategy: Facing Today’s Challenges and Preparing for Tomorrow

In an evolving regulatory landscape, the management of pharmaceutical impurities is becoming one of the most strategic aspects of drug development and lifecycle management. On October 7, 2025, Pharma D&S – a ProductLife Group company – hosted the webinar “Impurity Control Strategy: addressing today’s impurities and preparing for tomorrow’s challenges”, bringing together expertise and best practices to support companies in building structured and future-proof approaches.

From consolidated guidelines such as ICH Q3C and ICH Q3D, the pharmaceutical sector is moving towards a more dynamic, risk-based, and lifecycle-oriented model. The recent experience with nitrosamines has been a turning point, revealing the need for strategies that go beyond reactive measures and are fully integrated into a company’s Quality framework.

A well-defined Impurity Control Strategy (ICS) is no longer optional but an essential tool to ensure compliance, patient safety, and sustainability of processes. The challenge is not only to meet today’s requirements but also to anticipate future developments in order to maintain regulatory trust and operational efficiency.

The session provided participants with a comprehensive overview of the principles and practices required to establish an effective ICS. Topics included:

• The importance of a structured risk management system to identify, assess, and mitigate impurity risks

• How to integrate impurity control measures into existing quality systems, ensuring consistency across the product lifecycle

• The regulatory evolution that companies must monitor to remain compliant while supporting innovation

The presentation by Sara Cretella, Italy Impurities Service Area Manager at Pharma D&S, highlighted real-world considerations, offering participants both regulatory perspective and practical tools to implement in their daily operations.

For professionals working in quality assurance, compliance, manufacturing, and regulatory affairs, this webinar represented a valuable opportunity to strengthen their understanding of impurity control and to align strategies with the latest expectations from health authorities.

By combining technical expertise with regulatory insight, ProductLife Group – through Pharma D&S – continues to support Life Sciences companies in addressing one of the most pressing challenges of today’s industry: ensuring that impurity management is proactive, sustainable, and compliant.

🗓 Date: 7 October 2025 
🕒 Time: 11:00 AM CET 
📍 Format: Online | Free registration