Introduction
The release of the ICH Guideline for E&L Testing (Q3E) marks a big step forward for pharmaceutical and medical device industries. Extractables and leachables (E&L) testing plays a critical role in protecting patient safety by ensuring that harmful chemicals do not transfer from packaging or devices into medicines or the human body. With this new guideline, international rules are finally moving toward greater harmony, helping companies reduce repeated studies and regional compliance challenges.
At ResolveMass Laboratories Inc., our expertise in advanced E&L testing helps manufacturers align with these new global expectations. By adopting risk-based strategies early, companies can improve product safety, reduce delays, and ensure strong regulatory submissions.
Key Takeaways from the ICH Guideline for E&L Testing
- Introduces a globally consistent approach for E&L testing in drugs, biologics, and medical devices.
- Highlights the use of risk-based testing, validated methods, and toxicological evaluations.
- Reduces duplication of studies across regions, making submissions faster and smoother.
- Impacts pharmaceutical packaging, medical devices, and combination products alike.
- Working with expert labs like ResolveMass ensures tailored and compliant testing strategies.
The guideline is not just about meeting requirements—it’s about building patient trust and raising global quality standards.
What is the ICH Guideline for E&L Testing (Q3E)?
The International Council for Harmonisation (ICH) introduced the Q3E guideline to create a clear and unified process for extractables and leachables testing. This framework applies to drug formulations, medical devices, and combination products, all of which can pose risks if chemicals migrate into patients.
The guideline sets expectations for:
- Differentiating extractables from leachables.
- Applying risk-based assessment strategies.
- Using validated analytical tools such as LC-MS, GC-MS, and ICP-MS.
- Conducting toxicological evaluations like TTC and PDE.
- Preparing structured regulatory submissions.
By following these steps, companies can simplify global approvals and reduce the need for repetitive regional testing.
👉 For a deeper understanding of E&L processes, explore our resources:
Why the ICH Guideline for E&L Testing Matters
For years, pharmaceutical and device manufacturers faced different rules from regulators like the FDA, EMA, and others. This often caused expensive delays, duplicated studies, and confusion. The ICH Guideline for E&L Testing (Q3E) addresses these challenges by creating one standard.
With this guideline in place:
- Companies can rely on one framework instead of designing studies for each region.
- Approval timelines are expected to shorten due to harmonized data.
- Patient safety is enhanced because all risks are evaluated consistently.
- Manufacturers gain more certainty in planning development and submissions.
This alignment not only saves time and money but also increases confidence among healthcare providers and patients worldwide.
📌 Related guidance for compliance:
Extractables vs. Leachables: A Refresher
| Aspect | Extractables | Leachables |
|---|---|---|
| Definition | Substances released under controlled lab conditions. | Substances that actually migrate into the drug or patient system. |
| Purpose | Predict possible risks before real-world use. | Confirm actual risks during storage and patient exposure. |
| Risk Impact | Early-warning system for potential hazards. | Direct safety concern with real clinical outcomes. |
Both are critical. Extractables testing predicts future risks, while leachables testing confirms real exposure. Together, they provide a full picture of material safety.
Explore detailed analysis: Extractables vs. Leachables in Medical Devices
Major Highlights of the ICH Guideline for E&L Testing
Risk-Based Approach
Manufacturers must identify potential risks and design testing strategies that fit the product type and patient use scenario. This ensures resources focus on the most critical risks.
Advanced Analytical Methods
The guideline recommends the use of complementary tools such as LC-MS, GC-MS, and ICP-MS. These methods provide more accurate detection and quantification of unknown or low-level compounds.
Explore analytical techniques for E&L
Toxicological Relevance
Rather than collecting unnecessary data, the focus is on identifying compounds that matter to patient safety. Toxicological thresholds like TTC and PDE are used to guide evaluations.
Regulatory Data Requirements
Both biologics and devices must provide complete data packages, ensuring regulators have the right information to evaluate safety and quality.
Global Harmonization
The guideline aligns with USP, ISO 10993-18, and standards from FDA and EMA, creating one consistent framework. This reduces duplicated work and creates smoother approvals.
See ISO 10993-18 E&L Testing Guidelines
Impact of the ICH Guideline for E&L Testing on Medical Devices
Medical devices that use plastics, polymers, coatings, or packaging are directly impacted. Examples include:
- Prefilled syringes, inhalers, and drug-delivery devices.
- Implantable devices where long-term exposure may be risky.
- Packaging that comes in direct contact with medicines.
Although testing may increase initial development costs, the benefits outweigh the challenges. Companies can expect fewer recalls, reduced regulatory barriers, and stronger trust from both patients and regulators.
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Cost and Compliance Considerations
One challenge manufacturers face is balancing costs with compliance. The ICH guideline may extend testing timelines and require more detailed studies. Costs vary depending on:
- The material and complexity of the product.
- The type of device or drug packaging.
- Analytical techniques required for detection.
- Depth of toxicological risk assessment.
While upfront expenses may rise, harmonization helps save money in the long term by avoiding duplicated testing in multiple regions. Companies that act early will enjoy faster approvals and stronger market positioning.
👉 For detailed insights:
How ResolveMass Laboratories Helps with ICH Guideline for E&L Testing
At ResolveMass Laboratories Inc., we provide specialized services to help companies comply with the ICH Guideline for E&L Testing. Our support includes:
- Designing studies customized to product type and regulatory needs.
- Using validated analytical techniques for accurate detection.
- Performing risk-based toxicological evaluations to protect patient health.
- Preparing submission-ready reports for FDA, EMA, Health Canada, and ICH global standards.
By working with experienced partners like ResolveMass, manufacturers can reduce risk, save time, and ensure global compliance.
📌 Additional resource: E&L Testing Checklist for Medical Devices
Conclusion
The ICH Guideline for E&L Testing (Q3E) is a game-changer for the pharmaceutical and medical device industries. It promotes global harmonization, strengthens patient safety, and gives companies a clear path for regulatory compliance.
At ResolveMass Laboratories Inc., we guide our clients through these new expectations with expert study design, cost-effective strategies, and complete regulatory support. Compliance with ICH Q3E is not just about meeting rules, it can become a true competitive advantage.
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To explore ICH-compliant E&L testing solutions, consult with our experts today:
10 Most Asked FAQs on ICH Guideline for E&L Testing
The ICH Q3E Guideline provides a unified global standard for extractables and leachables (E&L) testing across pharmaceuticals, biologics, and medical devices. Its goal is to harmonize requirements worldwide, reducing duplicate studies and ensuring consistent patient safety standards.
Unlike USP <1663>/<1664> or ISO 10993-18, which are region- or application-specific, ICH Q3E offers one globally harmonized framework. This reduces regulatory confusion and creates consistency across international markets, making compliance smoother and faster.
The guideline highlights advanced analytical tools like LC-MS, GC-MS, ICP-MS, NMR, and FTIR. These techniques allow precise detection, identification, and quantification of chemical compounds to ensure thorough safety evaluations.
Yes, packaging that comes into direct contact with a drug must undergo extractables and leachables testing. This ensures that no harmful chemicals migrate from the packaging into the drug during storage or use.
Toxicological assessment helps determine whether detected compounds pose a real safety risk to patients. Using approaches like the Threshold of Toxicological Concern (TTC) or Permitted Daily Exposure (PDE), it establishes safe limits for exposure.
E&L studies can take anywhere from 8 weeks to 6 months, depending on the type of product and testing required. Planning early and working with experienced laboratories can help speed up the compliance process.
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References
- European Medicines Agency. (2025). ICH Q3E extractables and leachables scientific guideline. EMA. https://www.ema.europa.eu/en/ich-q3e-extractables-leachables-scientific-guideline
- International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use. (2025). ICH Q3E: Extractables and leachables (Step 2 draft guideline). ICH. https://database.ich.org/sites/default/files/ICH_Q3E_EWG_Step2_DraftGuideline_2025_0704.pdf
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