Resources
With our deep research and rich experience, we provide such resources for your better understanding about CCI and Zholion.
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![ECA released Version 3.0 of "The GMP/GDP Questions & Answers Guide."]( "ECA released Version 3.0 of \"The GMP/GDP Questions & Answers Guide.\"")
ECA released Version 3.0 of "The GMP/GDP Questions & Answers Guide."
This guide compiles common and challenging questions in GMP/GDP practices in a Q&A format.
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![FDA 2026 Draft Guidance: What Pharmaceutical Manufacturers Need to Know About CCIT]( "FDA 2026 Draft Guidance: What Pharmaceutical Manufacturers Need to Know About CCIT")
FDA 2026 Draft Guidance: What Pharmaceutical Manufacturers Need to Know About CCIT
FDA’s 2026 Draft Guidance on Container Closure Systems for Human Drugs and Biological Products introduces updated recommendations for container closure integrity testing (CCIT), with particular emphasis on sterile products, method validation, worst-case conditions, stability studies, transportation and storage, and advanced deterministic integrity testing technologies.
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![How to Align CCIT with USP <382> Requirements]( "How to Align CCIT with USP <382> Requirements")
How to Align CCIT with USP <382> Requirements
This guide outlines how to align Container Closure Integrity Testing (CCIT) with USP <382> requirements. It covers deterministic high-sensitivity methods (e.g., helium mass spectrometry), validation strategies to achieve MALL sterility at the 0.1–0.3 μm level, defect sample systems, and full lifecycle management—ensuring sterile barrier compliance for injectable drug packaging and biologics.
