The new European Guidelines on Good Distribution Practice (GDP) of Medicinal Products for Human Use have been issued on March 7th after several months of work and review. This new version has been updated in order to take into account the increased complexity of the Pharma logistics and the variety of medicinal products characteristics.
In the transportation chapter (Ch 9), it outlines “the responsibility of the supplying wholesale distributor to protect medicinal products (…) and to ensure that temperature conditions are maintained within acceptable limits during transport”. “A risk-based approach should be utilized when planning transportation.”
From our analyze, this new guidelines reinforce the current Pharma logistics organization but also:
- Broadens the covered scope, including all types of temperature sensitive products
- And certainly increases the necessity to document and formalize the decisions and choices.
Anticipating thoses trends, Kalibox offers an increasingly important range of insulated packaging providing a high level of performance with a very cost effective approach.