GDP (Good Distribution Practice) are the European guidelines that define how medicines must be stored, transported and handled throughout distribution, to guarantee their quality and integrity up to delivery. In Italy, oversight sits with AIFA.
What they require
GDP covers, among other things: temperature control and recording (cold chain), management of temperature excursions and deviations, qualification of vehicles and suppliers, batch traceability, a documented quality system and trained staff.
Why they matter for distribution
For intermediate distributors (DIF), GDP compliance is a condition to operate and is subject to audit. Turning it into operating procedures — especially on temperature and transport — is concrete work: see the AIFA GDP audit checklist.
FAQ
Are GDP and GMP the same thing?
No. GMP (Good Manufacturing Practice) concerns production; GDP concerns distribution (storage and transport). They’re complementary along the supply chain.
Who must comply with GDP?
Everyone who distributes medicines at wholesale, including intermediate distributors. Compliance is verified through authorisations and audits by the competent authority.