Good Distribution Practice

Good Distribution Practice governs the storage and transport of medicinal products through the supply chain (EU GDP 2013/C 343/01 and equivalents) — the part of the lifecycle after a product leaves the manufacturer and before it reaches the patient. Its job is to preserve the quality and integrity built at manufacture and to keep falsified medicines out of the legitimate chain.

A perfectly manufactured product can still be ruined in distribution — a broken cold chain, a temperature excursion, or a falsified-medicine infiltration undoes everything upstream. GDP is where supply integrity is defended, and its failures translate directly into degraded product reaching patients or shortages when compliant supply is disrupted.

Qualified storage and transport with mapped temperatures, monitored conditions, and defined limits — so cold-chain and ambient products stay within their labelled storage range end to end.

Trading only with authorised suppliers and customers, verifying licences, and applying due diligence that keeps the distribution network legitimate.

Validated shipping lanes and packaging that hold conditions through the real-world transport a product will actually experience, including worst-case seasons and routes.

Controls against falsified medicines entering the supply chain — verification, tamper-evidence, and handling of suspected falsifications.

• ›Temperature mapping of storage areas and vehicles
• ›Management of excursions — assessment, decision, and product disposition
• ›Handling of returns, recalls, and suspected falsified products
• ›Wholesale distribution authorization and qualification of trading partners

Derived from the 6 standards SPEQ decodes for this discipline.