PDA Midwest Chapter: Chemistry Extractables and Leachables

The PDA Midwest Chapter is pleased to have a lab tour and technical presentation at Nelson Labs in Itasca, IL for our June 2024 event to focus on topics related to Chemistry Extractables and Leachables testing for the pharmaceutical industry.

Presentations

Submissions to the FDA: What to Watch Out for From a CRO Perspectives. Presented by: Raymond Colton, Director of E&L Services, Nelson Labs.

Two decades following the release of the FDA Draft Guidance on Container/Closure Systems for Packaging Human Drugs and Biologics, the FDA has recently communicated informal updates regarding common observations when reviewing submissions to the Agency (CDER). These communications include general advice and specific expectations aimed at optimizing study design, evaluation, and reporting—elements not addressed in the original 1999 Draft Guidance Document.

This presentation will highlight the major observations from the FDA, explaining the origins of these updated requirements and offering guidance on addressing them effectively. Case studies from a CRO perspective will be presented to bolster these new viewpoints. Furthermore, the revised expectations from the FDA will be examined, alongside recommendations on incorporating them into the design, interpretation, or reporting of a container/closure system qualification program, particularly from an extractables/leachables (E/L) perspective.