Pharmaceutical logistics is subject to the strictest requirements – and rightly so. After all, products that can save or improve lives must maintain their efficacy and safety from the production site to the patient. The high quality requirements are based on clearly defined, comprehensive standards that are anchored in Good Distribution Practice (GDP). Only selected logistics companies such as SupplyX, which have GDP certification, are permitted to carry out these highly sensitive transports. We explain which standards apply and where the challenges lie.
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What does GDP include?
There are many regulations when it comes to transporting pharmaceutical goods. They include the WHO guidelines, the German Medicines Act, Good Manufacturing Practice (GMP) and Good Distribution Practice (GDP). The latter is an internationally recognized set of rules that regulates the storage, transport and handling of these sensitive goods. The aim is to ensure the integrity of medicinal products, in order for them to reach the end user in perfect condition.
The GDP requirements are described in detail in the EU guidelines (2013/C 343/01) and include for example:
- Quality Management Systems (QMS) for the development, implementation and monitoring of suitable processes,
- Precise documentation for seamless traceability of every movement within the supply chain,
- Continuous temperature monitoring using appropriate technologies to ensure that defined temperature ranges (e.g. 36-46 degrees Fahrenheit, or 59-77 degrees Fahrenheit) are maintained,
- A risk analysis to identify and minimize potential risks in logistics
- The qualification of staff to ensure that all employees work in accordance with GDP standards.
These guidelines are not optional – they are required by law and mandatory for anyone who manufactures, stores or transports pharmaceutical products.
The challenges of GDP-compliant logistics
Compliance with GDP guidelines requires a deep understanding of logistical processes, a distinctive risk management, specific know-how and the use of state-of-the-art technologies. After all, the transportation of pharmaceutical goods is demanding for a variety of reasons:
1. Temperature sensitivity of the products
Pharmaceutical products such as biologics, vaccines and blood plasma are highly sensitive to temperature fluctuations. Even slight deviations from the intended temperature range can impair the effectiveness of the medicines or render them unusable.
2. Complexity of global supply chains
Many modern supply chains span multiple climate zones, regulatory frameworks and numerous stakeholders. This complexity increases the likelihood of disruptions and requires seamless coordination between all supply chain partners.
3. Traceability must be ensured
The complete traceability of a product is a central aspect of GDP. Every phase of transportation, every environmental impact and every transfer of responsibility must be precisely documented. This is a particular challenge in multinational supply chains with many transfer points.
4. Dealing with risks
Complex supply chains are prone to disruptions, be it due to unforeseen events such as extreme weather conditions, delays caused by customs clearance or technical problems with refrigeration systems. Reliable risk management is necessary to minimize the impact of such disruptions.

SupplyX visits partner company Jeena in India.
Transport of pharmaceutical goods only with GDP certification
Not every logistics company is authorized to transport pharmaceutical products. GDP certification is required to ensure compliance with GDP standards. It serves as proof that the company in question consistently implements and maintains the strict regulatory requirements.
In addition to a comprehensive QMS, the vehicles, equipment, storage facilities and technical systems used to handle pharmaceutical products must also be validated in order to obtain certification. This includes:
- the calibration of temperature monitoring systems,
- the validation of cooling systems and packaging solutions
- as well as ensuring that vehicles do not exert any negative influences such as vibrations or moisture on the products.
SupplyX uses intelligent data loggers, for example, which record and document the temperature profile during the entire transportation process.
In addition to extensive staff training, GDP certification also requires the logistics company to pass external audits in the course of which independent auditors assess compliance with GDP standards. These audits include both a review of the documentation and the practical implementation of the requirements.
Conclusion: GPD – a standard that is binding and protects
GDP is not an isolated set of rules. On the contrary, it is a central component of a responsible pharmaceutical supply chain. Strict requirements apply to the transportation of pharmaceutical goods in order to prevent loss of drug efficacy due to contamination and to ensure hygiene standards and patient safety. Those rules promote quality assurance and create the basis for transparency and trust in a highly regulated market. Specially trained logistics companies such as SupplyX play a decisive role in this context: by consistently implementing GDP, they ensure the integrity of the products and make an essential, sustainable contribution to healthcare.