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Under Germany’s pharmaceutical regulatory framework, the storage of pharmaceuticals—whether in laboratories, refrigeration units, sales areas, warehouses, or receiving and shipping areas—is governed by the Pharmacy Operations Ordinance (ApBetro), Pharmaceutical wholesale operations must also comply with the provisions regarding storage and transportation set forth in the Pharmaceutical Trade Ordinance and the EU GDP Guidelines.
Globally, WHO Annex 9 also explicitly requires that pharmaceutical storage areas undergo temperature distribution validation (mapping) and be equipped with appropriate temperature and humidity control mechanisms to prevent product deterioration, contamination, or degradation. In this context, temperature distribution validation has become a decisive prerequisite for obtaining regulatory approval.
Before the German leading online pharmacy group, apo.com Group, put its state-of-the-art Autostore system in Mark-Kleberg into operation, it faced an urgent task: It must be demonstrated that the temperature distribution verification complies with GDP requirements in order to meet regulatory audit requirements. . However, the validation results previously conducted by an external service provider under no-load conditions failed to meet the approval standards, leading to repeated delays in the system’s launch. To make matters worse, the Autostore is crisscrossed by an intricate network of overhead conveyor systems, The measurement points must be positioned four meters above the ground, which is extremely difficult to implement. The
“Every day the warehouse is delayed in becoming operational results in direct financial losses for the company,” admitted Robert Kudrass, Manager of Legal Affairs at apo.com Group. “We’ve already wasted a lot of time because the first temperature distribution validation failed to yield clear conclusions. We have to get it right the first time on the second attempt.”
On the recommendation of a colleague, Robert Kudrass contacted Hongke ELPRO ...and purchased 10 temperature loggers. The GxP service experts at Hongke ELPRO not only provided the hardware but also proactively took on the entire process of implementing the temperature distribution validation and preparing the documentation.
Based on the completed Extensive experience with over 500 mapping projects and more than 10,000 facilities successfully mapped Hongke ELPRO has established a rigorous workflow: based on architectural drawings and on-site surveys, it plans internal and external measurement grids; survey points are placed at corresponding height levels to conduct a 72-hour temperature distribution validation; results are recorded and analyzed to identify cold spots and hot spots within the building (ambient temperature range: 15°C to 25°C); thereafter, a plan for continuous temperature monitoring is developed, and a complete documentation package required for regulatory approval is compiled.
At the implementation level, faced with a four-meter elevation difference and the challenges posed by a complex conveying system, the GxP experts demonstrated exceptional creativity. —With the Autostore system shut down, hang the temperature loggers on the cables and position them at different heights to create a measurement grid covering both the interior and exterior.
“Our GxP service expert not only demonstrated extensive experience but also showed remarkable creativity—he balanced himself on a work cart four meters above the ground to find the ideal installation location for the temperature logger.” Based on this innovative approach, Hongke ELPRO also developed risk-based documentation to enable external auditors to understand and approve this implementation method.
In the end, Less than two months after completing the temperature distribution validation for the empty Autostore warehouse, the facility met all the requirements to successfully pass regulatory validation. . Based on the collected data, Hongke ELPRO service experts compiled various reports required for regulatory audits, which was a prerequisite for obtaining a pharmaceutical wholesale license and approval to implement the Autostore system.
The success of this project has led the apo.com Group to place full trust in Hongke ELPRO’s professional services. . Since then, the Group has continued to collaborate with Hongke ELPRO to conduct temperature distribution validation in other areas of the Markkleeberg site—including the receiving area, laboratories, and pharmacy. In 2021, temperature distribution validations were also completed at the Emmerich transshipment warehouse and the advanced warehouse in Duiven, the Netherlands.
In addition, given the outstanding scalability of the Hongke ELPRO system, the Group decided to deploy the elproMONITOR EMS automated temperature and humidity monitoring solution to continuously and long-term meet the requirements for continuous temperature monitoring set forth in the EU GDP guidelines. “The monitoring system is now successfully operational in Markkleeberg, We can easily replicate this model in other locations or building areas and scale it in a way that perfectly aligns with our development pace and functional needs. ", Robert Kudrass concluded.
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