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Close-up of a small frosted vial with a red and white cap on a surface, with additional similar vials and a blue light in the background.

Ultra Cold Storage Package System Qualification

Cold storage introduces risk to container closure integrity of pharmaceutical products. The new EU GMP Annex 1 requirements specifically state that ‘The container closure integrity validation should take into consideration any transportation or shipping requirements that may negatively impact the integrity of the container...'


This flyer describes a program defined by LIGHTHOUSE to qualify your primary packaging with respect to cold storage and transport to comply with EU GMP Annex 1. The program is designed as a holistic, science-based approach generating data throughout the product life cycle.