“Because Almac is a service provider with hundreds of clients, we needed a software solution that allowed us to use a wide range of temperature monitors and collect data from any stakeholder in the supply chain,” Donna Christopher, Global Vice President of Operations for Almac Clinical Services, told us. “Our clients wanted the same flexibility because it was difficult for them to standardize monitor usage as they don’t have input on monitor choice for every stakeholder in their supply chains.”
The Good Distribution Practice (GDP) compliant platform builds a complete temperature history for a product at a lot or serialized level and works for both clinical and commercial products. The TempEZ solution is also able to collect planned and unplanned excursions as well as in-transit and storage temperature data.
“This is what allows the system to build a complete temperature history,” explained Christopher. “Without the storage data and the planned excursions, it is not possible to compile the full temperature profile of a product.”
Additionally, Christopher said the software provides “the underpinning” of the company’s Temperature Management services.
“The global Almac Temperature team can supplement a client’s internal efforts to manage excursions, site compliance, and cumulative life cycle,” she said.
Good Distribution Practice
In order to ensure GDP compliance, Heather Bogle, Supply Chain Solutions Manager of Almac Clinical Services, told us the company needed to have a solid understanding of the GDP regulations, as well as how these regulations are interpreted by inspectors and customers.
“TempEZ was developed with this in mind to ensure the quality and integrity of the product has been maintained by following the guidelines laid out in 2013/C 343/01 ,” she said.
This includes functionality such as electronic approval workflows and standard built-in processes to manage deviations occurring during transit (2013/C 343/01 section 9.2), as well as the ability to link shipping data to monitor data and excursion result to assess delivery routes using a risk-based approach (2013/C 343/01 section 9.1).
According to Bogle, the main challenge in ensuring compliance was working through the different interpretations of GDP regulations by customers depending on country or region.
“Although there are global groups within the industry that have formed with the goal to harmonize the interpretation, that will be an ongoing effort and we needed to design a platform that met our customers’ needs,” explained Bogle. “The functionality within TempEZ allows the most conservative approach to the GDP’s as well as flexibility within the set-up to handle these different views.”