Extractables & Leachables

Short description

Over the last years, the requirements on the assessment of substances that could leach into the drug product in the course of its life cycle have increased considerably.

The specific kind of extractable/leachable can vary from organic oligomers and catalyst residues to heavy metals – to name a few. Due to the resulting complexity, it is very important to consider the potential risk factors associated with leaching substances already at a very early stage in process development.

In addition, within Europe and the USA, it is mandatory to execute E&L assessments, especially in cases of packaging for injectables. Therefore, the ICH is currently working on a new ICH Q3E Guideline for Extractables and Leachables (E&Ls) to “assist both applicants and regulators by providing focus on critical aspects, and improving transparency in requirements for medicinal products including drug delivery device components”.

Packaging materials have been in the focus of such investigations for a long time as the contact time between drug product and packaging material is rather long. Recently, particular attention was paid to devices and equipment used in the production process, e.g. filters, bags, tubes.

This 1-day training course aimed at professionals involved or interested in risk assessment and safety testing of pharmaceutical products, will provide up-to-date knowledge needed to fully understand the risk factors and control & management of E&L's. 

Objectives

In this training you will learn:

• how to evaluate potential risk factors associated with leaching substances
• how to design extractables studies as part of material qualification and selection
• how to control and manage the life cycle of E&Ls
• how to assess the toxicological risks of E&Ls

Target group

The course is designed for staff of pharmaceutical companies and their suppliers who:

• are responsible for setting up E&L studies and E&L tests.
• work in quality control of packaging materials.
• specify and select polymeric, glass and rubber materials, devices and single-use equipment in process development and manufacturing.
• develop strategies for sourcing materials.