This flyer describes a program defined by LIGHTHOUSE to qualify your primary packaging with respect to cold storage and transport in compliance with EU GMP Annex 1. Designed as a holistic, science-based approach, the program generates robust data throughout the product life cycle.

Cold storage introduces specific risks to the container closure integrity of pharmaceutical products, particularly during transportation and shipping.

The new EU GMP Annex 1 requirements explicitly 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,” reinforcing the need for a structured, data-driven qualification program.