GDP

Good Distribution Practice

GDP covers the part of the supply chain where a correctly manufactured product can still be ruined: storage and transport. Its scope runs from the manufacturer’s release through wholesalers, brokers, and logistics providers to the point of dispensing, and it exists because temperature excursions, poor handling, and inadequate security destroy quality that GMP already established.

Two obligations dominate. The first is temperature control across the whole journey — qualified warehouses, mapped storage areas, validated shipping lanes and packaging, calibrated monitoring, and a defined procedure for assessing excursions against stability data rather than discarding or accepting product by instinct. The second is supply-chain integrity: buying only from and supplying only to authorised parties, verifying licences, and maintaining records that allow a batch to be traced in both directions.

Falsified medicines are the reason the rules tightened. The EU GDP guidelines (2013) and the Falsified Medicines Directive built in safety features and verification, and in the US the Drug Supply Chain Security Act phased in serialisation, transaction traceability, and verification obligations. Returns handling is a persistent weak point — returned stock may only re-enter saleable inventory under narrow, documented conditions where storage conditions can be assured.

• —Covers storage and transport from manufacturer release to dispensing.
• —Temperature control end to end: qualified warehouses, mapped areas, validated lanes and packaging.
• —Excursions are assessed against stability data, not judged by instinct.
• —Deal only with authorised suppliers and customers; verify licences and keep bi-directional traceability.
• —Returns re-enter saleable stock only under narrow, documented conditions.
• —Anti-falsification: EU FMD safety features and verification; US DSCSA serialisation and traceability.

EU: Guidelines on Good Distribution Practice of medicinal products for human use (2013/C 343/01) and Directive 2011/62/EU (Falsified Medicines Directive); US: Drug Supply Chain Security Act (2013) under FD&C Act §581-584; WHO TRS 1025 Annex 7; EU GDP for active substances (2015/C 95/01).