Cold Storage Package System Qualification

Cold storage (< -60℃) introduces risk to container closure integrity (CCI) 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 (e.g. by decompression or extreme temperatures).’

Discover a program to qualify your primary packaging with respect to cold storage and transport to comply with Annex 1. The program is designed as a holistic, science-based approach generating data throughout the product life cycle. This approach can be generalized to RT and refrigerated products as well.