Good Distribution Practice (GDP) is a set of Europe-wide guidelines and standards for the distribution of pharmaceuticals. These guidelines ensure that medicines and pharmaceutical precursors remain of impeccable quality and effectiveness throughout the entire supply chain. What exactly does GDP regulate? What makes a transport GDP-compliant? What should companies in the Life Sciences & Healthcare sector consider?
To Whom Do the EU Guidelines for Good Distribution Practice Apply?
The EU guideline on “Principles of Good Distribution Practice of active substances for medicinal products for human use” (EU Guidelines 2015/C 95/01) applies to all companies in the EU involved in the manufacture, storage, transport, or distribution of medicinal products. This includes primarily pharmaceutical manufacturers, wholesalers, logistics service providers, and pharmacies – but ultimately, any company or service provider involved in this process.
Introduced in 2013, the guideline enables seamless control over the entire supply chain of finished medicinal products and active pharmaceutical ingredients (APIs). It consolidates regulations to ensure the quality and integrity of medicinal products from storage and transport to sale in pharmacies.
Therefore, it encompasses every stage, from the laboratory to the pharmacy. This includes the production, transport, and distribution of medicines and APIs. Recently, mail-order pharmacies and the delivery of pharmaceuticals to customers have become an additional topic of interest.
What Does GDP Transport of Medicines Involve?
GDP transport is the shipment of pharmaceutical products that fully complies with the EU GDP Directive requirements. For transport service providers and internal logistics teams, maintaining the quality of medicines and APIs during transport is of central importance.
What Is the Purpose of the EU GDP Directive?
The guidelines on the distribution of pharmaceutical products do not represent excessive bureaucracy; rather, they ensure the supply of high-quality, effective medicines to the European population.
- GDP ensures that medicines are packaged, stored, and transported under controlled conditions to protect their efficacy.
- The GDP also includes traceability measures that prevent counterfeit or stolen medicines from entering the legal supply chain.
What Makes the Transport of Medicines GDP-Compliant?
The requirements for GDP-compliant transport are outlined primarily in chapter 6 of the EU GDP guidelines. To protect the efficacy and quality of medicinal products, these requirements include:
- APIs must be transported under the conditions specified by the manufacturer.
- The identity of the product, its batch, and its transport container must be always maintained.
- There must be a system to trace the whereabouts of each batch of medicine and API to facilitate a recall.
- Any information or incident that could compromise the quality or supply of the product must be reported.
- Deliveries within the EU are permitted only between registered producers, distributors, and pharmacies.
Necessary Measures for Transport Service Providers
GDP-compliant pharmaceutical transport places high demands on carriers in the field of pharmaceutical logistics. The following measures are essential for meeting EU standards and manufacturer specifications:
- Compliance with hygiene regulations
- Maintaining and controlling the required temperature and humidity
- Use of special packaging that meets conformity and safety requirements
- Continuous monitoring systems
- Continuous quality control of all processes
- Complete documentation across the entire supply chain for traceability
- Established emergency and recall procedures
- Regular audits
- GDP training for employees
Who Monitors GDP Compliance?
Responsible companies ensure GDP compliance during storage and transport by using monitoring technologies, conducting internal audits, and providing training. Companies with a GDP certificate undergo additional audits by the issuing testing agency.
Since the pharmaceutical industry concerns human health, GDP compliance is also ensured by regulatory authorities. This applies to both manufacturing (Good Manufacturing Practice – GMP), and distribution. Competent state authorities, known as GMP/GDP inspectorates, carry out regular inspections. They evaluate production facilities, warehouses, vehicles, logistical processes, and supporting documents, for example.
What Should Pharmaceutical Companies Consider When Selecting Logistics Partners?
According to the EU GDP guidelines, companies in the Life Sciences & Healthcare sector that outsource the transport of medicinal products to logistics service providers have due diligence obligations concerning transport. They are required to:
- check the service provider’s suitability, including business license and financial stability;
- conclude a separate agreement with the service provider regarding quality;
- regularly review the quality of the service provider by checking current certificates, conducting personal interviews, and arranging audits.
What Are the Benefits of GDP certification?
It is important to note that transport companies are not required to have GDP certification, nor is there an official GDP certificate. Although companies that handle medicinal products must comply with GDP guidelines, a certificate is not mandatory. Nevertheless, a GDP certificate can be useful.
- Pharmaceutical companies must ensure that their logistics partners comply with GDP criteria. GDP certification by recognized certification agencies facilitates the selection and verification of service providers’ GDP compliance.
- In turn, by obtaining certification, logistics companies can position themselves as reliable and qualified service providers for pharmaceutical supply chains and accelerate approval procedures.
What Criteria Are Typically Considered for a GDP Certificate?
Certification agencies for GDP compliance focus on areas that are crucial for safe processes in pharmaceutical logistics. Therefore, they primarily audit:
- Quality management within the company
- Employee qualification
- Status of premises and equipment (e.g., refrigeration technology, vehicles, tracking systems)
- Comprehensive documentation and traceability
- Safety of operational processes
How Much Does GDP Certification Cost?
The cost of GDP certification varies depending on the size and complexity of a company. There is a distinction between internal and external costs.
- Internal costs arise from employee training, technical adjustments to premises and vehicles, and the purchase of control systems, for example.
- External costs for audits and consulting by testing agencies depend on the provider. Every certification is calculated individually.
How Can You Ensure that Your Transport Is GDP-Compliant?
All participants in the Life Sciences & Healthcare sector are responsible for ensuring the quality of their products, as well as their storage and transport. DHL and DHL Freight take this responsibility seriously and are experienced logistics partners for pharmaceutical companies whose top priorities are health and safety.
Competent and GDP-certified partners ensure GDP compliance for pharmaceutical transport. The Dekra certification agency has awarded DHL Freight GDP certification in more than 20 countries. The certificate applies to all DHL Freight business areas and locations where GDP-compliant full truckload (FTL) transports are offered, including its subsidiaries.
DHL Freight Is GDP Certified for Pharmaceutical Transports
f. l. t. r.: Daniel Schümmer – Global Head of Certification DHL Freight, Tim Breithaupt – Key Account Manager Germany ...
This proves that DHL Freight meets the high standards of the GDP guidelines for transporting pharmaceutical products. GDP compliance is ensured by a seamless, cross-border, end-to-end transport chain; intelligent tracking for temperature control and other purposes; regular internal training and audits; and a dedicated team of life sciences experts.
What Are the GDP Regulations Outside the EU?
Worldwide, there are regionally varying GDP guidelines for the transport, storage, and distribution of medicinal products. However, they are all based on the World Health Organization’s (WHO) recommendations for good distribution practices.
It is worth noting that the EU GDP guideline aligns with the WHO’s GDP recommendations. Therefore, anyone with an EU GDP certificate can be quite sure that they comply with regulations in other regions of the world.
Excellence in Pharmaceutical Transport – Now and in the Future!
DHL is deeply committed to the Life Sciences & Healthcare sectors, as well as to patient care. To meet the dynamic requirements of the pharmaceutical industry and ensure a global supply of patient care, DHL Group is strategically investing two billion euros in integrated global healthcare solutions between 2025 and 2030.
But you don’t have to wait until 2030 for innovative healthcare solutions. The cooperation between DHL Freight and SkyCell shows what modern, GDP-compliant services look like today. SkyCell’s refrigerated containers are high-tech transport systems for pharmaceutical products. DHL Freight not only carries these containers but also inspects, cleans, and reconditions them.
GDP compliance can be sustainable. Our collaboration with the pharmaceutical manufacturer Alexion is proof of this. Switching from diesel to hydrogenated vegetable oil (HVO) reduces greenhouse gas emissions from pharmaceutical transport by up to 90 percent in ten European countries.
When it comes to health and responsibility, we always strive to improve. DHL Freight can help you comply with GDP regulations by delivering your pharmaceutical shipments safely, efficiently, and quickly.
FAQs on GDP-Compliant Transport and GDP Certification
1. What does the abbreviation GDP mean?
GDP stands for “Good Distribution Practice” and refers to the best practices for distributing pharmaceutical products. It comprises Europe-wide guidelines and standards for pharmaceutical logistics, ensuring the quality and safety of medicinal products.
2. What are the GDP guidelines?
The GDP guidelines are issued by the EU Commission to stakeholders in the pharmaceutical sector, including manufacturers, wholesalers, logistics service providers, and pharmacies. These guidelines ensure that medicinal products and pharmaceutical precursors remain of impeccable quality and effectiveness throughout the entire supply chain. The guidelines cover all steps in the supply chain, from laboratory to pharmacy.
3. What is GDP transport?
GDP transport is a shipment of medicinal products, active pharmaceutical ingredients (APIs), or pharmaceutical precursors and intermediates that fully complies with the requirements of the EU GDP guidelines. For transport service providers and internal logistics departments, maintaining the quality of medicinal products and active ingredients during transport is paramount.
4. What is GDP certification?
GDP certification is a non-governmental certificate issued by an independent testing agency that confirms a company’s GDP compliance. To this end, testing agencies audit quality management, employee qualifications, premises and equipment, documentation, and operational processes, among other things.
5. How much does GDP certification cost?
The cost of GDP certification varies depending on a company’s size and complexity. Internal costs include employee training, technical adjustments, and purchasing control systems. External costs arise from audits and consultations by certification agencies. These costs depend on the provider and are calculated individually.
6. How can GDP compliance be achieved?
The prerequisites for GDP compliance are intelligent monitoring of processes such as storage and transport, complete documentation and traceability, as well as regular internal training of employees and audits. GDP certificates offer extra security. In addition, competent and GDP-certified logistics service providers ensure GDP compliance for pharmaceutical transports.
