Extractables and Leachables USA 2024

Date: May 21-22, 2024
Location: Bethesda Marriott, Bethesda, MD, 20814

FEATURED SPEAKING SESSION

Speaker:

Vicki Ward Ph.D.
Sr. Manager, Analytical R&D
Morrisville

Title: Extractable and Leachable Risk Assessment for a Pharmaceutical Manufacturing Train Utilizing USP <1665> and <665>
Date: May 22nd, 2024
Time: 9:30 am ET
Abstract: Catalent has a systematic process in place to incorporate E&L risk assessments in its pharmaceutical manufacturing train. The primary goal of this process is to ensure product safety and compliance with USP <1665> and <665> throughout all stages of manufacturing. This systematic approach involves an initial assessment, identification and quantification of risks, and the assignment of characterization levels to develop a robust risk mitigation strategy. Catalent uses risk dimension scores and clinical mitigation factors to evaluate the risk of leachables in systems used in the manufacture of pharmaceutical products. A case study will illustrate the application of the USP <1665> and <665> framework to perform an E&L manufacturing risk assessment and how this can support drug sponsors in obtaining regulatory approval.