E&L Readiness Webinar Series

As the first dedicated ICH guideline focused on extractables and leachables, Q3E is expected to shape future regulatory expectations and harmonise approaches across global markets. In this first webinar of Intertek's Extractables & Leachables Readiness Series, our expert will examine the draft guideline, comparing its requirements and recommendations with existing industry guidance and standards.

ICH Q3E, as indicated in the guidance document, aims to provide “a holistic framework and process for the assessment and control of leachable impurities.” The guidance goes beyond current regulatory guidance in providing expanded thresholds based on route of administration and duration of treatment. The guidance also expands upon the classification of leachables and provides limits applicable for leachables from the different classes. Opportunities exist to leverage the approaches presented within the guidance. However, as with most new guidance, additional detail may result in expanded analytical workflows. This webinar, presented by Louis Fleck, Laboratory Manager, Trace Organic Analysis Group, will review the content of the guidance and will discuss opportunities for early adoption, including examples where the expanded thresholds may provide opportunities for simplified study implementation.  

Key learning points:

• Understand the scope, objectives and key provisions of draft ICH Q3E
• Compare Q3E with existing global E&L guidance and standards.
• Identify opportunities for early adoption and implementation.
• Explore implications for study design.
• Highlight opportunities for simplified study implementation.
  
  

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USP <1663> provides detailed definitions for identification categories, including tentative, confident and confirmed.  Each level of identification requires a particular set of supporting evidence and consequently a particular level of effort.  This presentation will review the identification categories, provide context where tentative identification can be acceptable and discuss risks of incorrect or incomplete (tentative) identification.

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Applying new USP <665> and USP <1665> requirements through science-based risk assessment and robust analytical strategies.

As the implementation date for USP <665> approaches, pharmaceutical and biopharmaceutical manufacturers are facing important decisions around material qualification, risk assessment, and extractables testing strategies for single-use systems and manufacturing process components.

In this webinar, part of Intertek's Extractables & Leachables Readiness Series, our experts will share practical insights into implementing USP <665> and USP <1665> through risk-based approaches and scientifically justified analytical programmes. The session will explore how extractables studies can be designed for low-, medium-, and high-risk materials used throughout pharmaceutical production lines, and how data can be leveraged to support compliance while avoiding unnecessary testing.

Drawing on real-world industry experience, we will review case studies spanning a range of manufacturing materials and applications, highlighting common challenges encountered during study design, execution, data interpretation, and regulatory review. Attendees will gain practical guidance on selecting appropriate analytical methodologies, applying risk frameworks effectively, and addressing technical obstacles to support efficient and compliant implementation of USP <665>/<1665> requirements.

Key Learning Points

• Understand the practical implications of USP <665> and USP <1665>
• Apply risk-based approaches to material qualification and extractables studies
• Design extractables studies for low-, medium-, and high-risk manufacturing materials
• Review real-world case studies from pharmaceutical manufacturing systems
• Learn how to address common testing challenges and data interpretation issues

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Sterile filtration systems play a vital role in pharmaceutical manufacturing and product protection. This webinar examines extractables and leachables considerations for sterile filters, including risk assessment approaches, study design, analytical challenges, and regulatory expectations to help ensure product quality and patient safety.

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