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FDA (CDER)
GUIDANCE DRAFT
Q3E Guideline for Extractables and Leachables: Supporting Documentation: Class 3 Leachable Monographs
Published: 11/28/2025Detected: 3/20/2026

Summary preview

Clarifies the supporting documentation expectations under ICH Q3E for extractables and leachables assessments, with specific monographs intended to support Class 3 leachables qualification.

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manufacturing
quality
safety
#extractables and leachables
#ICH Q3E
#container closure system
#leachable monographs
#Class 3 leachables

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