Extractables & Leachables: Regulatory Aspects, Risk Assessment and Design of Experiment for Drug Products

Simone Carrara, Business Unit Manager E&l And Packaging Testing Unit, Eurofins BioPharma Product Testing Italy, Vimodrone, Italy (simonecarrara@eurofins.com)

A drug product container-closure system should not release chemicals that can accumulate in the drug product in quantities sufficient to present a risk of toxicity, or to affect its stability or efficacy. As substances may migrate from different materials the patients may be exposed through different routes of administration. It is important to evaluate the potential for various chemicals to migrate. FDA and international regulators require testing to identify any risks of product adulteration associated with extractables and leachables. Failure to demonstrate material safety results in failure to receive regulatory approval for a product.

The evaluation of the container closure system and single use systems (SUS) is fundamental to guarantee the safety of pharmaceutical products. Consequently, E&L studies are now a crucial component of product release. Regulatory authorities require the execution of analytical activities according to specific experimental designs. The implementation of an adequate risk assessment, the definition of testing conditions and extracting solvents, the selection of analytical techniques, and reporting threshold to be applied as well as a proper toxicological evaluation are among the most important aspects to consider.

This presentations aims to provide a comprehensive overview of the most relevant and critical aspects, technical considerations and strategies for establishing an extractables study design that provides meaningful data for the pharma industry.

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Short Biography of Presenting Author

Simone Carrara

Simone holds a Biotechnology degree from the University of Milan and has a vast experience as bio-analytical researcher, through LC/MS method development for Pharmacokinetics analysis and ADMET profiling. In his previous role as Project Leader he has successfully managed different projects including analytical method development and validation with LC/MS-GC/MS, and drug product impurities characterization. In the last 7 years he has been focusing on extractables & leachables studies to support drugmanufacturing companies to fulfill regulatory requirements. He is currently the E&L Business Unit Manager, in Eurofins BioPharma Product Testing in Italy.