Extractables and Leachables Conference 2013

Topics

• Identifying Extractables and Leachables from production process or intermediate storage and integrating QbD with E&L approach
• Step- wise approach of performing Extractables and Leachables study for PODP, OINDP’s and ophthalmic
• Discussion on the USP chapter for Extractables and Leachables and developing a tactical approach
• Updates on PQRI recommendations for Extractables and Leachables in combination products and biologics
• Toxicological review in Extractables and Leachables data and risk mitigation strategy to reduce or tackle Extractables and Leachables
• Importance of selecting the extraction techniques & establishing the significance of Analytical Evaluation Threshold (AET)