GDP requirements on pharmaceutical transport

Darja Paveljeva

Business Development I Life Science & Healthcare

2 December 2024

Good Distribution Practice (GDP) refers to a set of guidelines and standards for pharmaceutical companies that ensure the proper distribution of pharmaceutical products to maintain their quality, safety, and efficacy throughout the entire distribution process. This includes various processes such as procurement, purchasing, storage, transportation, repackaging, relabeling, documentation, and recording in accordance with the GDP guidelines.

GDP has been developed and implemented by various regulatory authorities and industry organizations worldwide. It is important to note that while there are regional GDP guidelines in place, they are all rooted in the recommendations provided by the World Health Organization (WHO) for Good Distribution Practice. The EU GDP guidelines are widely recognized for their stringent adherence to these recommendations, indicating that pharmaceutical companies that have been granted the EU GDP certificate are likely to be in compliance with GDP requirements in their respective regions of origin¹.

This article provides an overview of the requirements that pharmaceutical customers have for transport companies² according to the EU GDP guidelines³.

Pharmaceutical manufacturers and wholesalers must adhere to the Good Distribution Practice (GDP) guidelines when shipping human medicines and active substances for medicinal products for human use within the EU³.

Compliance with GDP is monitored through regular inspections by local authorities (GMP inspectorates)⁴ within the pharmaceutical industry.

According to the GDP guidelines, pharmaceutical companies are required to:

1. Assess the suitability of service providers (e.g., transport companies, procurement services) including business permits and financial status.

2. Establish a separate quality agreement with the service provider in addition to general contractual terms and conditions and transportation agreements.

3. Regularly assess the quality of the service provider through reviewing current certificates (ISO 9001), conducting discussions, and scheduling audits.

The key requirements for transport companies according to EU GDP guidelines are outlined in Chapter 7⁵. The focus is on the quality and integrity of the delivered products as well as compliance with the legal supply chain during transportation.

It is important to note that there is no specific applicable GDP certification or regulatory GDP certificate for transport service providers!

For DHL EXPRESS pharma customers, it is possible to ship pharmaceuticals nationally and internationally in accordance with GDP guidelines, if they do not require active temperature-controlled transportation⁶. DHL EXPRESS enables worldwide express shipping of medications by offering validated passive temperature-controlled packaging for all the common temperature ranges in pharmaceutical industry, including the packaging solutions with liquid nitrogen, dry ice and phase-change materials (PCMs) as well as the utilization of passive and active temperature loggers to ensure the quality of the delivered products. The integrity of pharmaceutical transportation is ensured by the TAPA certification⁷.

As mentioned earlier, there is no specific applicable GDP certification or regulatory GDP certificate for all transport service providers, including DHL EXPRESS. However, DHL EXPRESS supports the implementation of GDP requirements for customers and provides a written GDP Quality Assurance Agreement (QAA)⁸ according to Chapter 7 of the EU GDP guidelines for pharmaceutical companies, as well as the possibility of conducting audits. By signing the GDP Quality Assurance Agreement additionally with a DHL EXPRESS contract, the pharmaceutical customer meets requirement to the transportation company according to Chapter 7 of the EU GDP.

1 If you have any questions about GDP guidelines that do not pertain to the EU GDP guidelines, please feel free to contact DHL Express.

2 Transport companies are pure transport service providers specializing in the transportation of goods and do not operate their own storage facilities.

3 Important: Veterinary medicinal products are not covered in EU GDP Guide, but GDP principles can be adopted by pharmaceutical manufacturers and wholesalers based on a risk assessment on a voluntary basis.

4 GMP inspectorate is an organization or unit within a regulatory authority responsible for inspecting and auditing companies involved in the manufacturing of medicinal products and veterinary medicinal products to ensure compliance with Good Manufacturing Practice (GMP) standards.

5 Chapter 7 Outsourced Activities from EU Guidelines for Good Manufacturing Practice for Medicinal Products for Human and Veterinary Use

6 There is the possibility to request active temperature-controlled transport through DHL Express' specialized Same Day (SD) department.

7 The TAPA certification stands for "Transported Asset Protection Association" and is an internationally recognized standard for security measures in the transportation and logistics industry. The TAPA certification aims to ensure the security of goods and assets during transportation, protecting them from theft and other risks.

8 GDP QAA (Quality Assurance Agreement) by DHL Express is a regulatory QAA that has already passed several inspections by the competent authorities.