What FDA CRLs Reveal About CCIT

Container closure integrity testing (CCIT) is a critical safeguard for product sterility, stability, and patient safety. Yet recent FDA Complete Response Letters (CRLs) show that deficiencies in CCIT strategy, validation, and documentation continue to delay regulatory approvals.

From selecting methods with insufficient sensitivity to incomplete validation packages and inadequate stability testing, even small gaps can have significant regulatory consequences.

Our white paper analyzes recent FDA CRLs to uncover the most common CCIT pitfalls and provides practical strategies for designing robust, regulatory-ready CCIT programs. Learn how to select the right testing approach, validate methods appropriately, and generate the evidence needed to support successful submissions.