ICH Q3E : How the new guideline reshapes your Extractables & Leachables (E&L) studies

📃 ICH Q3E is set to reshape how Extractables & Leachables (E&L) studies are designed and controlled. Released as a draft in August 2025, the guideline is currently under international public consultation and will aim to harmonise E&L requirements worldwide. It has already drawn extensive feedback, not least across Europe.

So what could it actually mean for your pharmaceutical products? Here’s what you need to know.

3 key shifts to prepare for

1. A mandatory risk-based approach

One-size-fits-all protocols applied across every product are on their way out. ICH Q3E requires you to justify your study design based on the specific risk profile of your product, its container closure system, and its route of administration. In practice, every study will need to be purpose-built and scientifically rationalised.

2. Toxicological safety assessment at the core

Identifying and semi-quantifying extractables will no longer be enough. ICH Q3E puts toxicological risk assessment at the heart of the process, with safety thresholds to be documented and the overall strategy justified within the regulatory dossier.

3. A more targeted approach to leachables

In line with this, developing compound-specific methods to reliably quantify the leachables flagged by the risk assessment (i.e. those to be monitored on stability) will be preferable to relying on generic screening methods.

What this means for you

Three questions are worth asking right now:

• Will your ongoing E&L studies hold up against the principles of ICH Q3E?
• Has your analytical service provider adapted its approach accordingly?
• Can your dossier justify the rationale behind your control strategy?

How CEBIPHAR can support you

As trace analysis specialists, we bring our expertise to the targeted monitoring of identified leachables, making CEBIPHAR your strategic partner in meeting these new expectations.

The value of an E&L study isn’t measured by the number of compounds detected, but by its ability to support a sound regulatory decision based on the data generated.

📩 Have an E&L study in the pipeline or a question about ICH Q3E? Let’s talk with our team.