ECA Updates Best Practices for Container Closure Integrity Testing

The European Compliance Academy (ECA) Visual Inspection Working Group has released version 3.0 of its Position Paper on Container Closure Integrity (CCI) Testing for parenteral products. Designed to complement pharmacopoeial monographs, the guidance reflects current GMP expectations observed during inspections and outlines a lifecycle approach integrating qualification, routine controls, supplier management, and stability studies.

Key updates include expanded interpretations of Annex 1 clauses 8.22–8.28, distinguishing fusion-sealed containers (requiring 100% integrity testing) from mechanically closed systems (where risk-based CCIT sampling and validated process controls suffice). The paper emphasizes scientifically justified sampling plans, verification of vacuum in lyophilized products, transport validation, and stopper-height detection as critical in-process controls. Prefilled syringes are now fully incorporated into the CCI framework, with guidance on stopper and tip-cap validation and PPQ sampling. CCI verification within stability programs is also highlighted to ensure integrity over shelf life.

The updated Position Paper is available free to ECA Visual Inspection group members via the group’s website.

24-11-2025