--- title: "Extractables & Leachables and ICH Q3E: What Has Changed and What Hasn't" description: "Discover what the draft ICH Q3E guideline means for Extractables & Leachables programmes, from lifecycle management and documentation to risk-based decision-making." url: https://qbdgroup.com/en/blog/extractables-leachables-ich-q3e-what-has-changed type: "Blog post" language: en published: 2026-06-24 author: "Javier López" publisher: "QbD Group" citation: "QbD Group, \"Extractables & Leachables and ICH Q3E: What Has Changed and What Hasn't\", https://qbdgroup.com/en/blog/extractables-leachables-ich-q3e-what-has-changed" --- # Extractables & Leachables and ICH Q3E: What Has Changed and What Hasn't > Discover what the draft ICH Q3E guideline means for Extractables & Leachables programmes, from lifecycle management and documentation to risk-based decision-making. The publication of the draft ICH Q3E guideline in 2025 marked an important step toward global harmonisation of Extractables & Leachables (E&L) requirements. As with any new ICH guideline, the first question many organisations ask is straightforward: what needs to change? With Q3E, the answer is nuanced. Much of the underlying science remains familiar. The fundamental principles supporting E&L assessments are not being rewritten. What is changing is the level of structure, documentation, consistency, and lifecycle thinking expected around E&L programmes. Although the consultation period has closed and the final version is still pending, the draft already provides valuable insight into the future direction of E&L regulation. More importantly, it helps distinguish between the principles that remain unchanged and the areas where regulatory expectations are clearly evolving. **In this blog post:** - What the draft ICH Q3E guideline introduces - Which E&L principles remain unchanged - Where regulatory expectations are evolving - How organisations are already adapting their E&L programmes - What Marketing Authorisation Holders should prioritise today ## Which Extractables & Leachables Principles Remain Unchanged Under ICH Q3E The primary objective of E&L assessments remains the same: ensuring that compounds migrating from packaging systems, manufacturing equipment, delivery devices, or other product-contact materials do not compromise product quality or patient safety. The core scientific principles remain equally relevant. Regulators continue to expect manufacturers to: - Apply risk-based approaches - Generate reliable analytical data - Assess patient exposure appropriately - Perform toxicological evaluations where required Likewise, existing regulatory expectations remain fully applicable. The draft Q3E guideline does not replace current regional requirements, nor does it remove the need for scientifically justified E&L programmes supported by robust documentation. For organisations with mature E&L programmes already built around sound scientific principles, this should be reassuring. The science remains the foundation. ## What ICH Q3E Changes for Extractables & Leachables Assessments The most significant contribution of the draft guideline is not the introduction of new scientific concepts. It is the creation of a more structured framework. Historically, E&L programmes have relied on a combination of regional guidance documents, industry recommendations, and internal company procedures. While this approach has generally been effective, it has also led to variation in methodology, documentation practices, and justification strategies across organisations and regulatory jurisdictions. ### A More Harmonised Framework for Extractables & Leachables ICH Q3E aims to reduce this variability by providing a harmonised framework that links risk assessment, risk control, and risk review throughout the product lifecycle. The draft guideline places greater emphasis on the documentation supporting E&L decisions. Particular attention is given to: - Justification of analytical thresholds - Toxicological qualification strategies - Study design rationale - Testing approaches and decision-making processes Many organisations already apply these principles today. However, Q3E formalises expectations that have historically been interpreted differently across the industry. As a result, consistency becomes just as important as scientific validity. ## The Growing Importance of Lifecycle Management Perhaps the most important practical shift introduced by the draft guideline is the increased focus on lifecycle management. **The most significant practical shift is the move from submission-focused E&L assessments toward lifecycle-managed E&L programmes.** Traditionally, E&L activities have often been viewed primarily as part of a marketing authorisation submission package. Q3E presents a broader perspective. Rather than treating E&L assessments as one-time activities, the draft positions them as part of an ongoing process that should evolve alongside the product. This includes periodic review as: - Products evolve - Suppliers change - Packaging systems are updated - Manufacturing processes are modified The expectation is not simply to generate E&L data, but to maintain confidence that E&L risks remain adequately controlled throughout the product lifecycle. ## How the Draft Is Already Influencing Industry Practices Even before publication of the final guideline, many organisations are reviewing their E&L programmes against the direction outlined in Q3E. Documentation quality is one area receiving particular attention. Regulatory agencies increasingly expect transparent scientific justification alongside analytical data. As a result, companies are placing greater emphasis on documenting: - Why studies were performed - Why certain studies were not considered necessary - How analytical thresholds were selected - How toxicological conclusions were reached Lifecycle management is another area gaining importance. E&L assessments are increasingly being integrated into: - Change control systems - Supplier qualification programmes - Post-approval product management activities Rather than being treated as isolated submission requirements. The draft also reinforces the need for collaboration between analytical scientists, toxicologists, quality teams, and regulatory affairs professionals. Maintaining a consistent risk-based approach throughout the product lifecycle requires close interaction between these functions. ## Looking Ahead Although the final version of ICH Q3E may still evolve following review of stakeholder comments, the overall direction appears increasingly clear. Future E&L programmes are likely to place greater emphasis on: - Harmonised risk assessment methodologies - Lifecycle management principles - Documentation and traceability - Scientifically justified decision-making Rather than introducing entirely new requirements, the guideline appears focused on creating greater consistency in how existing principles are applied across products, organisations, and regulatory regions. For pharmaceutical companies, this should be viewed as an opportunity. Organisations that strengthen their programmes now will be better positioned not only for future implementation of Q3E, but also for improving the quality, consistency, and defensibility of their current E&L activities. ## Key Considerations for Marketing Authorisation Holders To remain prepared for future developments, Marketing Authorisation Holders should consider the following actions: - Review existing E&L programmes against the principles described in the draft ICH Q3E guideline. - Ensure analytical strategies, threshold calculations, and toxicological evaluations are fully documented and scientifically justified. - Verify that E&L assessments are integrated into lifecycle management and change control processes. - Reassess supplier management practices and the availability of supporting material data. - Maintain clear traceability of decisions, assumptions, and risk assessments to facilitate future regulatory review. - Strengthen collaboration between analytical, toxicological, quality, and regulatory functions. Organisations that address these areas today will be better positioned for the future implementation of ICH Q3E while simultaneously strengthening the quality and defensibility of their current E&L programmes. ## Strengthening Your Extractables & Leachables Strategy As regulatory expectations around Extractables & Leachables continue to evolve, organisations should ensure their programmes remain scientifically robust, well documented, and aligned with lifecycle management principles. QbD Group supports pharmaceutical companies with: - Extractables & Leachables strategy development - Toxicological risk assessment - Analytical study design and interpretation - Supplier and material risk assessment - Lifecycle management and regulatory support **Talk to our Extractables & Leachables experts about preparing for the future implementation of ICH Q3E.** ## References 1. International Council for Harmonisation (ICH). *Q3E Guideline on Extractables and Leachables*. Step 2b Draft Guideline. 2025. 2. European Medicines Agency (EMA). *ICH Q3E Extractables and Leachables Scientific Guideline*. 3. European Medicines Agency (EMA). *ICH Q3E Guideline on Extractables and Leachables*. Public Consultation Documents. 2025. 4. Medicines and Healthcare products Regulatory Agency (MHRA). *Guidance and Regulatory Expectations for Pharmaceutical Quality and Lifecycle Management*. 5. International Council for Harmonisation (ICH). *Q9(R1) Quality Risk Management*. 2023. 6. European Medicines Agency (EMA). *Guideline on Plastic Immediate Packaging Materials*. CPMP/QWP/4359/03. 7. European Medicines Agency (EMA). *Supporting guidance related to lifecycle and risk-based quality approaches*. --- Source: https://qbdgroup.com/en/blog/extractables-leachables-ich-q3e-what-has-changed — © QbD Group. Quote freely with attribution and a link back.