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.
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.