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Large Pharma Company Utilises Almac’s Excursion Management Solution to Meet New Good Distribution Practice (GDP) Regulations
As a result of updated Good Distribution Practice (GDP) regulations, a large pharmaceutical company started including temperature monitors into a large percentage of their clinical site shipments. The purpose was to monitor the shipment payload’s temperature and determine if additional shipment controls were required. The company’s plan was to review the results and manage excursions based on predefined stability criteria.
Many of the company’s shipments employing the temperature monitors were processed utilising a cardboard corrugate shipper rather than a validated insulated shipper to conserve distribution costs. The products had a wide stability profile; therefore, an insulated shipper was not deemed necessary.
Almac provided assistance by processing the high volume of temperature excursions, which stemmed from in-transit or clinical site storage issues. The dedicated staff, available in multiple time zones, worked closely with the client and Supply Chain Managers (SCM) to identify and expedite processing of an excursion when there was a patient or client impact.
Through the use of Almac’s excursion management services and dedicated team, the average turnaround time for an excursion was improved to match the rapid pace of the study. In addition, the Almac’s Supply Chain Managers (SCM) reviewed recruitment and dosing data to determine any upcoming patient visits to the site.
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