Pharmaceutical Cold Chain: A Major Concern For The Unknown

By Gary Hutchinson

Cold chain subject matter expert, Gary Hutchinson, president of Modality Solutions, has been named a columnist for Cold Chain IQ - Temperature Control Logistics and Quality Network.

A drug can take a variety of paths from the manufacturer to the patient. Most often, the product leaves the manufacturer's direct control and enters a complex system of handoffs.

Manufacturers are obligated to include distribution as part of their overall quality system and should be continuously monitored and updated to adhere to industry best practices.  Current Good Distribution Practices (cGDPs) for the pharmaceutical supply chain have been divided into seven different categories (Stability, Distribution Control Management, Performance Management, Supply Chain Partner Management, Qualification / Validation, Continuous Improvement, and Import / Export Compliance) in PDA Technical Report #52.

Maintaining the cGDP quality system for transportation, third-party distribution, and product protection is a difficult challenge because of the distributed nature and contracted third-party relationships found across most modern controlled-environment logistics networks. Coupled with the increased focus on high-growth protein products that are environmentally sensitive, the concerns during transportation are heightened for several reasons: