Search
Free Trial

Hongke's latest articles

HongKe

Lorem ipsum dolor sit amet, consectetur adipiscing elit. Ut elit tellus, luctus nec ullamcorper mattis, pulvinar dapibus leo.

Lorem ipsum dolor sit amet, consectetur adipiscing elit. Ut elit tellus, luctus nec ullamcorper mattis, pulvinar dapibus leo.

[Hongke Solutions] Hongke ELPRO Helps Clients Complete Regulatory Approval Preparations Within Two Months

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.

01 Challenge: High Technical Difficulty and Time Pressure

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.”

02 Hongke ELPRO GxP Solutions: Professional Expertise and Innovative Approaches

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.

03 Results: Compliance Implementation Within Two Months and a Long-Term Partnership

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.

Go to Elpro Product Page

Other Articles
Hongke Case

[Hongke Solution] Autonomous Driving Simulation Hybrid Rendering Solution – 3DGS and NeRF High-Fidelity Reconstruction

Hongke has launched an autonomous driving simulation hybrid rendering solution that combines the real-time splash rendering capabilities of 3DGS with the reconstruction advantages of NeRF. It supports multi-modal data output from cameras and LiDAR, as well as HIL (Hardware-in-the-Loop) testing, effectively addressing the challenges of domain offset and scene fixation.

Read more
HongKeTechnology August 18, 2026
Hongke Dry Goods

[Hongke Insights] How Can Real-World Road Scenarios Be Replicated in the Lab? Enhanced NMEA Playback Revolutionizes GNSS Scenario Replication Capabilities

An In-Depth Analysis of Enhanced NMEA Playback Technology. By combining messages such as GGA, GSV, and GSA with carrier-to-noise ratio data, this technology accurately recreates real-world GNSS road scenarios—including urban canyons and multipath interference—overcoming the limitations of traditional NMEA and IQ/RF recording methods, and enabling the validation of positioning algorithms for autonomous driving and the low-altitude economy.

Read more
HongKeTechnology August 13, 2026
Hongke Dry Goods

[Hongke Solutions] How Can Hong Kong Companies Prevent Phishing and Data Breaches? From Compliance Training to Employee Risk Management

The latest data from Hongke and the PCPD shows a sharp surge in phishing and data breaches in Hong Kong! Relying solely on rigid technical safeguards and annual training is no longer sufficient to prevent AI-powered social engineering. This article provides an in-depth analysis of how Hong Kong B2B enterprises can transition to “Human Risk Management,” effectively comply with the PDPO and financial regulatory requirements, and establish a zero-trust defense against human-related risks.

Read more
HongKeTechnology August 12, 2026
close menu icon

Contact Hongke to help you solve your problems.

Let's have a chat