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Several clear glass vials with red caps partially filled with a white substance are arranged on a white surface with a blurred background, highlighting the importance of Container Closure Integrity Testing.

Compliance Program for EU Annex 1 Container Closure Requirements

The new EU GMP Annex 1 contains new requirements for the container closure integrity (CCI) of sterile pharmaceutical products. These requirements will trigger new industry best practices in the area of CCI.

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This flyer presents a program defined by LIGHTHOUSE to comply to Annex 1 CCI requirements, focusing on vials, syringes, and cartridges. The program is designed as a holistic, science-based approach generating robust statistical data throughout the product life cycle.