Good Distribution Practice guidelines for pharmaceutical products apply around the world at different levels of regulation and requirements. Here is what pharma logistics professionals need to know about GDP regulations across borders.
When it comes to transporting pharmaceutical products, GDP (Good Distribution Practice) is the rulebook everyone talks about — but not everyone plays by the same version. The goal of GDP is the same globally: to protect the quality, safety, and integrity of medicines during distribution. But depending on where you are in the world, the guidelines, enforcement, and level of detail can vary significantly.
If you’re managing international supply chains or scoping partners in different regions, these differences are key to staying compliant.
The EU GDP Guidelines: The Global Gold Standard
The EU GDP guidelines (2013/C 343/01) are widely considered the most comprehensive and rigorous. They cover everything from temperature control and documentation to training and audits, with clearly defined expectations for every player in the distribution chain — including carriers. What makes EU GDP stand out is its enforceability. Member states are required to implement it into national law, and certifications are issued by local health authorities. For many pharmaceutical companies around the world, EU GDP is the benchmark, even outside of Europe.
If your logistics partner has EU GDP certification, it’s a strong sign of reliability.
USA GDP Guidelines: Strong on Manufacturing, Looser on Distribution
In the United States, GDP is not in a single unified document. Instead, elements are scattered across various FDA regulations, particularly 21 CFR Part 211, which focuses more on manufacturing than distribution. As a result, there is no formal GDP certification for logistics companies. Distributors must ensure product integrity, but carriers are often left out of the regulatory spotlight.
This means due diligence is critical. You’ll want to dig deeper with questions, documentation requests, and possibly audits to confirm that a carrier operates to GDP-level standards. Alternatively, a logistics vendor with an EU GDP verification can ensure a high level of compliance.
China GDP: Regulated but Evolving Fast
In China, GDP is part of the Good Supply Practice (GSP) regulations issued by the NMPA (National Medical Products Administration). These are binding laws, not just guidelines, and they place high requirements on logistics providers. These include temperature control, traceability, staff training, and more. However, the regulation landscape in China is evolving quickly. What was compliant two years ago might not be enough today.
For companies working in or through China, regular reassessment and local expertise are essential.
WHO GDP Guidelines: A Global Reference Point
The World Health Organization (WHO) GDP guidelines are not legally binding but often serve as a reference for national guidelines. Countries like India, many in Africa, and parts of Latin America may look to the WHO GDP as a foundation for their national policies. The EU GDP, the gold standard globally, also aligns with the WHO GDP.
While WHO GDP is helpful for setting a baseline, it’s less prescriptive than regional laws. This means that it’s up to companies to define and enforce standards internally or via contractual agreements with carriers.
Final remarks
For better or worse, GDP compliance isn’t one-size-fits-all. The rules change depending on geography, enforcement, and supply chain complexity. For logistics managers, this means you need to ask smart questions, verify certifications, and align on standards early — especially when your supply chain crosses borders.
At LEMAN, we work with GDP standards across all major regions, hold an EU GDP verification and know how to navigate the fine print. If you’re scoping logistics partners or need support building a compliant distribution strategy, our pharma logistics experts are here to help.