ICH Q3E: A New Risk-Based Framework for Extractables and Leachables in Pharmaceutical Products

Home » Article » ICH Q3E: A New Risk-Based Framework for Extractables and Leachables in Pharmaceutical Products

Understand How The Draft ICH Q3E Guideline Could Influence Your E&L Testing Strategy

Protecting patient safety and product quality starts with understanding the substances that could migrate into your pharmaceutical product from manufacturing systems, packaging and delivery devices.

This technical paper explores the proposed ICH Q3E framework and its potential implications for your extractables and leachables (E&L) programme. Gain a clearer understanding of the analytical and toxicological considerations that inform risk assessment, study design and ongoing lifecycle management.

Why Download?

Understand the proposed framework and what draft ICH Q3E could mean for your E&L programme.
Inform your testing strategy with insight into extractables, leachables and simulated leachables studies.
Clarify key safety considerations, including analytical thresholds, leachable classification and patient exposure.
Plan for lifecycle changes by understanding how materials, suppliers and product modifications can affect E&L risk.

Expert Insight From Cormica

Written by Luminita Moraru, Technical Leader – Medical Device Chemistry, the content draws on Cormica’s scientific expertise in chemical characterisation and E&L assessment.

Our expert scientists bring decades of experience supporting clients worldwide, helping manufacturers understand their products’ critical quality attributes.

Download The Free Technical Paper

Complete the form to access your PDF copy and explore what the proposed framework could mean for your E&L strategy.

Have a specific project in mind? Discuss your testing requirements with our team.

Download:

We will email you the link to the PDF file.

Author:

Luminita Moraru

Luminita Moraru is Medical Device Chemistry Technical Lead at Cormica Bradford, with extensive experience in Extractables &; Leachables (E&L), chemical characterisation and biocompatibility. An expert committee member for ISO 10993 and ISO 18562, she specialises in designing studies to support medical device safety assessments and regulatory compliance.

Laboratories near you, supporting global product success

With accredited laboratories in the UK, EU and US, we support pharmaceutical, medical device and combination product manufacturers worldwide. Local support combined with global quality, delivered by teams who understand your regulatory requirements.

Our Clients’ Experiences

The exceptional team at Cormica have been amazing at supporting our needs in both terms of testing, sterility predominantly, and advice in completing our projects. Their knowledge and focus on doing what is correct for the customer is second to none and the range of testing services they provide is exceptional....

After speaking with them at a trade show it became immediately evident that they were the ‘go-to’ group for the services we required. Their professionalism, clarity and honesty made them an easy choice to work with and working with them has most definitely optimised our business opportunities.

We collaborate with Cormica on several pharma projects, they have consistently demonstrated a high level of expertise, professionalism, and attention to detail in all aspects of CMC-related work, including formulation development, analytical method validation, and routine testing for stability studies...

We're very pleased with the testing conducted for us. Their team demonstrated exceptional professionalism and efficiency, and the results were delivered exactly as promised. They made the entire process seamless. We will definitely be returning for any future testing projects.

Cormica was able to carry out specialised testing for odour control and gas permeability services that no other labs we contacted were able to offer. The team was knowledgeable, professional, and easy to work with throughout the process. Their support made the experience smooth and efficient.

Working with the Cormica was a real pleasure. We had a very urgent matter for an extensive study with a critical schedule. Cormica's handling of this challenge was outstanding!

We’ve been impressed with Cormica’s sterility testing services. The team are very responsive and adaptable, with great turnaround times and consistent communication throughout our projects.