PPT Slide
LEACHABLES & EXTRACTABLES TEAM
Key Issues for Clarification and Agency Dialogue:
What are appropriate reporting/identification thresholds for leachables & extractables?
How is a correlation between leachables and extractables established?
What are appropriate practices for establishing safety of leachables?
Is extractables profiling appropriate for control of component composition?
Which critical components should be subject to routine extractables testing?
Process Employed to Investigate Key Issues:
- Collected drug product specific leachables and extractables data in order to investigate the concept of correlation
- Formed Toxicology Working Group to Address Toxicology Issues for Leachables
- Investigated current supplier practices for control of component composition and extractables profiles