FDA on the Issue of Packaging Components: Extractables/Leachables Control

Understanding extractables and leachables (E&L) is an essential element of determining the suitability of a packaging or delivery system for a drug product.  Recently, PDA presented an interview with Dan Mellon, Ph.D., Pharmacology Toxicology Supervisor at CDER’s Office of New Drugs, discussing FDA’s approach to evaluating E&L information

In particular, seven issues were discussed that can negatively impact a new drug product application:

• unidentified compounds above the qualification threshold
• inadequate sensitivity of detection methods
• use of inappropriate qualification thresholds
• inadequate stability data
• inadequate toxicology information
• inadequate description of how extractable data was used to design a leachable assessment
• inadequate E&L correlations

Further advice given was to be clear and detailed in how studies were designed and executed, to ensure use of proper measurement thresholds, and to consider at least three batches of drug product over time. Starting the E&L evaluation and consulting with FDA early are factors for success. E&L is a thrust area for West Analytical Services, having the expertise, staff, and facility, to design and execute E&L studies that meet FDA requirements on behalf of clients. For more on how West can help, please contact an account manager or Technical Customer Service representative.