This presentation will provide a structured, stepwise approach to conducting Extractables and Leachables (E&L) studies, addressing key challenges in material characterization, analytical method selection, toxicological risk assessment, and regulatory compliance. The session will explore best practices for E&L study design, leveraging techniques such as LC-MS, GC-MS, and ICP-MS to enhance the identification and quantification of extractables. Key topics covered include: • Regulatory expectations (FDA, EMA, USP < 1663>/ < 1664>, ICH). • Risk-based approaches for prioritizing critical leachables. • Case studies of E&L failures and their impact on product recalls. • Advanced analytical and toxicological strategies to improve safety assessments. Attendees will leave with a clear framework for executing E&L studies, ensuring regulatory alignment, data integrity, and patient safety.
Learning Objectives:
Analyze key regulatory requirements for E&L studies, including USP /, FDA, and ICH guidelines, to ensure compliance and effective risk assessment in pharmaceutical packaging and manufacturing.
Effectively plan E&L studies using a stepwise approach, considering formulation, dosage form, and toxicological risk assessment, to ensure comprehensive study design, robust data generation, and regulatory acceptance.
Calculate the Analytical Evaluation Threshold (AET), select appropriate analytical techniques, and integrate toxicological risk assessments to develop a scientifically justified, regulatory-compliant E&L study, strengthening regulatory submissions.
Assess and interpret the results of extractables and leachables (E&L) studies, and establish a correlation between controlled extraction and leachable studies.
Evaluate and implement strategies for comprehensive risk assessment of E&L studies, starting from vendor assessment to conducting E&L testing, to avoid regulatory submission delays.
