What Is GDP Certification? An Overview of the International Quality Standard Required for Pharmaceutical Transportation

What Is GDP?

GDP (Good Distribution Practice) is an international standard established to ensure the quality and safety of pharmaceuticals throughout the entire distribution process. It is designed to ensure that product quality is not compromised during transportation, storage, and handling, from the point of manufacture through to administration to the patient.

GDP has spread internationally based on guidelines established by the WHO, and in 2013 the EU incorporated the standard into its legal framework under the EU GDP Guidelines (2013/C 343/01). Today, it is regarded as the de facto industry standard for international pharmaceutical transportation.

Why Is GDP Necessary?

Pharmaceutical products, particularly biopharmaceuticals, biologics, and regenerative medicine products, are highly sensitive to environmental factors such as temperature, humidity, light, and vibration. If a temperature excursion occurs during transportation, there is a risk that product efficacy may be reduced or safety may be compromised.

The main reasons GDP has become increasingly important include the following. As biopharmaceuticals have rapidly become more widespread, the number of products requiring strict temperature control—such as antibody drugs, cell therapy products, and gene therapy products—has increased significantly. In addition, the expansion of global clinical trials has internationalized clinical supply chains, making cross-border transportation the norm. Regulatory authorities such as the FDA, EMA, and PMDA are also increasingly requiring logistics providers to operate in compliance with GDP.

Key GDP Requirements

The main requirements of GDP include the following:

• A quality management system (QMS), including documentation of all processes and procedures for handling deviations

• Personnel training and education, with regular training sessions and proper record retention

• Qualification and calibration of facilities and equipment, including temperature-controlled warehouses and transport containers

• Continuous temperature monitoring during transportation and storage, along with reporting and investigation procedures in the event of deviations

• Contractual assurance that external logistics providers comply with GDP, as well as regular audits of those providers
  

The Difference Between GDP and GMP

GMP (Good Manufacturing Practice) is a standard that applies to pharmaceutical manufacturing processes and quality control. GDP, by contrast, applies after manufacturing and serves as an extension of quality assurance into distribution, transportation, and storage.

No matter how strictly quality is controlled during manufacturing, it loses its value if the product is compromised during transportation or distribution.

About Annex 7 (Transportation of Biological Medicinal Products)

For temperature-sensitive products such as biologics, blood products, and vaccines, a supplementary guideline known as Annex 7 (EU GDP Annex 7) applies. This guideline places particular emphasis on prior validation of transport routes and shipping containers (Transportation Lane Qualification), continuous temperature monitoring throughout the entire cold chain, and GDP audit requirements for outsourced logistics providers.

The Status of GDP in Japan

In the EU, GDP certification is a legal requirement. In Japan, by contrast, there is a Japanese GDP framework (J-GDP) under the Pharmaceuticals and Medical Devices Act, but mandatory application to transport providers remains limited at present.

However, in practice, the importance of GDP certification is rising rapidly. This is driven by an increasing number of cases in which foreign pharmaceutical companies and CROs require transport providers to hold GDP certification, stronger regulation in the field of regenerative medicine, and the continued globalization of Japanese pharmaceutical companies.

THERMAL™ and GDP Compliance

THERMAL™, the biopharmaceutical logistics division of Hubnet Co., Ltd., continues to maintain WHO GDP certification (renewed in November 2025). Through its in-house customs clearance team, THERMAL™ maintains full chain of custody. Its pharmaceutical-dedicated warehouse at the Heiwajima operation center is a GDP-compliant temperature-controlled facility capable of handling +2 to +8°C, +15 to +25°C, -20°C, and -80°C storage requirements. Continuous in-transit temperature monitoring using single-use data loggers is provided as a standard service.

Frequently Asked Questions

Q. Are there any risks in using a transport provider that does not hold GDP certification?Yes. If a temperature excursion occurs during transportation, there is a risk that the investigation into the cause and the allocation of responsibility may become unclear. In cases involving exports to the EU or transactions with foreign pharmaceutical companies where GDP certification is a requirement, this may also create commercial or compliance issues.

Q. What is the difference between GDP and ISO 9001?ISO 9001 is a general-purpose quality management system standard applicable across industries. GDP, on the other hand, is an industry-specific standard dedicated to the distribution and transportation of pharmaceuticals, including temperature control, pharmaceutical-specific risk management, and regulatory compliance.

Q. Does GDP also apply to the transportation of investigational medicinal products (IMPs)?Yes, it does. Under EU regulations, GDP compliance is also required for the transportation of investigational medicinal products. In particular, for international multi-center clinical trials, it may be necessary for each transport provider involved in different countries to comply with GDP.

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Please feel free to contact us for any inquiries regarding GDP-certified transportation and cold chain logistics.