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What Is GDP (Good Distribution Practice)?

Good Distribution Practice: guidelines, such as the EU GDP guidelines and WHO guidance, that set quality standards for storing and distributing medicines, including temperature control, handling and traceability.

Term: GDP (Good Distribution Practice)Resource: Glossary
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Good Distribution Practice: guidelines, such as the EU GDP guidelines and WHO guidance, that set quality standards for storing and distributing medicines, including temperature control, handling and traceability.

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Detailed Definition

Good Distribution Practice describes how medicinal products should be stored, transported and handled after manufacture so their quality is maintained until they reach the pharmacy, hospital or patient. Key texts include the European Commission guidelines on GDP of medicinal products for human use and WHO guidance on good storage and distribution practices. Topics include a quality system, qualified personnel, premises and equipment, temperature control and monitoring, documentation and traceability, and handling of returns and falsified medicines. GDP is closely linked to GMP, which covers manufacturing.

What GDP expects from storage and transport

Under GDP, a distributor must show that products stayed within their labeled storage conditions throughout storage and transit. That usually means temperature mapping of warehouses, calibrated monitoring devices, qualified transport lanes, written procedures and records that let each batch be traced. Deviations such as a temperature excursion have to be documented and assessed before the product is released.

Where pallets come into GDP

GDP texts do not specify a pallet type, but pallets fall under the general requirements for clean, suitable equipment and for protecting products from contamination, damage and pests. In practice, pharmaceutical distributors and their quality teams set their own pallet rules, which may include:

A pallet supplier serving this market should expect a supplier qualification process and should ask the customer for its written pallet specification rather than assume one.

Related Glossary Terms

Frequently Asked Questions

Is GDP a law in the United States?

The term GDP is most closely associated with the EU guidelines and WHO guidance. In the US, drug storage and distribution are governed by FDA regulations such as the drug CGMP rules in 21 CFR Parts 210 and 211, the Drug Supply Chain Security Act and state licensing of wholesale distributors. Many US companies follow GDP principles because they ship internationally or because their customers require it, but the legal basis depends on the jurisdiction.

Does GDP require plastic pallets?

No GDP guideline we know of mandates a specific pallet material. Distributors decide based on risk: plastic pallets are easier to clean and do not shed splinters, while wood pallets are common in general warehouse areas. What GDP does require is that equipment is suitable, clean and does not put product quality at risk. The pallet policy should be written, justified in the quality system and applied consistently.

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