EU GDP Guidelines - Good Distribution Practice

What it says

The EU Good Distribution Practice Guidelines establish requirements for wholesale distributors of medicinal products, covering quality management, personnel, premises and equipment, documentation, transportation, and specific temperature control and monitoring expectations to maintain product quality throughout the distribution chain after manufacture.

Paraphrased for plain-language clarity. Always verify against the current published regulation text.

What it means in practice

• GDP governs the distribution and wholesale supply chain specifically, picking up where GMP's manufacturing-focused requirements end, together forming a connected quality assurance chain from manufacture through to the point of dispensing.
• Temperature-controlled transportation and storage is a particular emphasis area, given that many products carry specific storage condition requirements that must be maintained continuously through transport, warehousing and redistribution, not just within the original manufacturing facility.
• Wholesale distributors carry their own licensing and quality system obligations under this framework, distinct from but connected to the manufacturing authorisation and GMP compliance obligations that apply upstream at the manufacturing site.

What inspectors look for

• Whether temperature monitoring throughout transportation and storage genuinely demonstrates products remained within their required storage conditions continuously, not just at origin and destination.
• Whether distributor quality systems include documented procedures for handling temperature excursions, damaged product, and product quality complaints arising during distribution.
• Whether distribution records provide adequate traceability supporting recall capability, consistent with the same underlying principle behind manufacturing distribution records.

Related regulations