ICH Q3E and Extractables and Leachables (E&L)
The draft International Council for Harmonisation (ICH) Q3E guideline introduces the first globally harmonized framework for evaluating extractables and leachables (E&L) in pharmaceutical products and drug-device combination products. Building on existing industry guidance and risk management principles, ICH Q3E establishes a consistent approach to identifying, assessing, and controlling organic leachables throughout the product lifecycle.
Although the guideline is still in draft, it provides valuable insight into future regulatory expectations. Organizations developing injectable drugs, biologics, advanced therapies, inhalation products, and combination products can begin evaluating their E&L programs against the proposed risk-based framework to support future compliance and global submissions.
What is ICH Q3E?
ICH Q3E is a draft international guideline that establishes a science-based, risk-based approach for extractables and leachables assessments. It applies to new drug products, including biologics, advanced therapies, and drug-device combination products requiring marketing authorization.
The guideline introduces a harmonized framework for identifying potential leachables, evaluating patient exposure, performing toxicological assessments, and documenting the rationale behind study design. It also reinforces lifecycle management, recognizing that changes to formulation, packaging, manufacturing processes, or dosing may require reassessment of E&L risk.
Why is ICH Q3E Important?
For many organizations, the principles within ICH Q3E reflect current best practices. However, the guideline provides greater global consistency by aligning regulatory expectations for extractables and leachables testing under a single framework.
Key topics addressed within ICH Q3E include:
- Risk-based extractables and leachables strategies
- Hazard identification and risk assessment
- Analytical Evaluation Threshold (AET) derivation
- Extractables, leachables, and simulated leachables studies
- Safety assessment using a harmonized classification framework
- Lifecycle management for packaging systems, manufacturing components, and combination products
As adoption approaches, organizations should be prepared to clearly document why a particular testing strategy is appropriate for their product and demonstrate how scientific risk assessment supports study design and reporting.
Download the whitepaper to learn how the draft ICH Q3E guideline may influence future extractables and leachables programs, understand the proposed regulatory framework, and identify practical considerations for preparing E&L strategies before implementation.
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