ICH Q3E Impurity Guidelines: Assessment and Control of Extractractables and Leachables for Pharmaceuticals and Biologics.

Work on the ICH Q3E impurity Guideline is underway, and it provides a great opportunity for consolidation of thirty years of consideration on how to study and control the risk from leachables. In this presentation, I offer my view on what the focus areas for this guideline should be to enable clarity, consensus, and control of leachables. I hope for a single internationally agreed set of detection, identification, quantitation, and qualification thresholds for leachables as the bedrock upon which all drug product dosage forms are developed and maintained, using a science led and risk-based approach. I hope we can define and agree on common procedures and process steps for key parts such as risk management, testing of both extractables and leachables and where necessary mechanisms of control. All this is supported by a common glossary of terms which supports shared understanding and requirements for the benefit of all. Finally, I hope to demonstrate that knowledge management is a key enabler throughout, where knowledge and understanding is continuously shared and built upon to accurately measure the risk from leachables, and this, in turn, is reflected in the work undertaken.

Presented by Jason Creasey, Managing Director at Maven E&L Ltd

Jason Creasey is a graduate Analytical Chemist. He set up in 2019 as an independent consultant providing advice on the topic of extractables and leachables (E&L), after working for GSK in the area of extractables and leachables since the mid-1990s.

Over that time, he has seen demand in this area grow exponentially and Jason has held roles of increasing seniority in relation to providing support to extractables and leachables. Before setting up Maven E&L Ltd – a specialist consultancy for all things E&L related, he was the director of a team of analytical chemists who were responsible for GSK’s global R&D support for E&L activities across a wide range of product types and modalities.  He has had the pleasure of commenting on OINDP PQRI guidelines on E&L for GSK and co-authoring a chapter within a book entitled “Leachables and Extractables Handbook: Safety Evaluation, Qualification, and Best Practices Applied to Inhalation Drug Products”.

Since setting up Maven E&L; he continues to present, discuss, and write about E&L. He is a scientific advisor to Extractable and Leachable Safety Information Exchange otherwise known as ELSIE, and now is now publishing a regular E&L blog through LinkedIn and his Website (www.MavenEandL.com), most recently adding an E&L Forum for exchange of ideas. As well to supporting client projects, among recent E&L activity, he is working and commenting on risk-based approaches to E&L requirements that he hopes will form part of an ICH guidance in the not too distant future.

Sponsored by Nelson Labs
Nelson Labs, A Sotera Health company, is the leading, global provider of lab testing and expert consulting services. We perform microbiological and analytical laboratory tests across the medical device, pharmaceutical, and tissue industries. The company is regarded as a best-in-class partner with a strong track record of collaborating with customers to solve complex problems. We have over 700 scientists, technicians, and service specialists who diligently perform more than 700 rigorous tests in 13 global laboratory locations.

Based in Belgium, Nelson Labs Europe specializes in providing premium Extractables & Leachables testing services to the pharmaceutical and medical device industries. We also support pharmaceutical companies across the globe in developing worldwide compliance testing strategies to qualify container/closure applications and pharmaceutical production equipment from an Extractables & Leachables perspective.