What is GDP (Good Distribution Practice) for medicines? A plain-language explanation

GDP is the abbreviation of Good Distribution Practice. These are the guidelines the European Commission published on 5 November 2013 (2013/C 343/01), describing the minimum requirements a wholesaler of medicinal products for human use has to meet: how it sets up its quality system, which staff it has, how it stores, documents, supplies, handles complaints, recalls, outsources, inspects itself and transports. The aim is simple: the medicine the manufacturer released must arrive at the pharmacy or hospital in the same state, without anything having been stored wrongly, mixed up or falsified along the way.

In the glossary of the guidelines, transport is moving medicines between two locations without unnecessarily long storage, and holding is something else. That distinction returns in the question whether a carrier needs an authorisation. The abbreviation confuses people coming from another field: in economic texts GDP stands for gross domestic product. This article is about the medicines meaning. GDP is the counterpart of GMP, Good Manufacturing Practice: GMP covers manufacturing, GDP covers what happens to the product afterwards in wholesale distribution.

The European medicines directive (2001/83/EC) describes wholesale distribution as procuring, holding, supplying or exporting medicines, apart from supply to the public. Anyone doing that needs a wholesale distribution authorisation, and holders of such an authorisation are obliged to comply with the principles and guidelines of GDP. The Commission publishes those guidelines. Transporting as such is not part of the definition of wholesale distribution.

In the Netherlands this is transposed in the Medicines Act. It is prohibited to conduct wholesale distribution without an authorisation; the wholesaler must ensure that purchasing, storage and trading take place in line with the designated GDP provisions and must have a qualified person; the IGJ and the NVWA supervise. Pharmacies do not fall under GDP but under their own professional standards, and medical devices fall under the European regulations on devices and in-vitro diagnostics. So who has to comply with GDP: the wholesaler and the manufacturer. Who has to deal with it: everyone working for them, such as a carrier.

The guidelines have ten chapters and a glossary. Chapter 1 covers the quality system, 2 personnel (with, in section 2.4, the requirement that everyone carrying out wholesale activities is trained in GDP, with specific attention to temperature-sensitive products and a record of the training), 3 premises and equipment, 4 documentation, 5 operations (procurement, receipt, storage, supply), 6 complaints, returns, suspected falsified medicines and recalls, 7 outsourced activities, 8 self-inspections, 9 transportation and 10 brokers.

For transport, chapters 7 and 9 are the core. Chapter 7 governs outsourcing: a written contract with a clear division of tasks, a client that remains responsible and may audit, and no further subcontracting without its approval. Chapter 9 governs the transport itself: the supplying wholesaler is responsible, storage conditions stay within the limits of the manufacturer or the pack, deviations are reported and investigated, measuring equipment is calibrated at least once a year and delivery takes place to the addressee. There are no figures in it: 2-8 °C and 15-25 °C come from the pack, the manufacturer or supervisory policy. The detail per requirement is in GDP and transport; how the requirements work through into daily transport in medicine transport, and how temperature is measured and recorded in temperature logging in medical transport. Who remains responsible for what when transport is outsourced is explained in GDP responsibilities in outsourced transport.

GDP is not a quality mark a company can buy and not a course you finish with a certificate. A GDP certificate is issued by the inspectorate to a wholesaler, within ninety days of an inspection that has established that it complies with GDP, and according to the IGJ it is valid for at most five years. Certificates and statements of non-compliance are in the publicly accessible Union database EudraGMDP; a client can check there itself whether a party holds an authorisation and a certificate, and will also see that a pure carrier is not listed.

GDP is not a product standard or a temperature table either. The guidelines mention no temperature anywhere; they refer to what the manufacturer has established and printed on the pack. And GDP is not a law that applies to a courier itself: a company that only transports medicines and holds them for less than 72 hours needs, according to the IGJ, no wholesale distribution authorisation, but does have to observe the GDP rules under the supervision of the client that engages it. What a courier can and cannot say about GDP is explained in GDP training or GDP certificate.

A few questions that keep coming up in conversations with pharmacies and buyers, answered briefly.

• What is GDP in transport? The part of the guidelines that deals with transport (chapter 9), plus the rules on outsourcing (chapter 7): the wholesaler remains responsible, the carrier works under contract and supplies the proof.
• Is GDP mandatory? Yes, for holders of a wholesale distribution authorisation and for manufacturers; not for pharmacies (professional standards) and not directly for a carrier without an authorisation, which encounters it through the contract.
• Can a courier be GDP-certified? No. A GDP certificate is issued to a wholesaler after an inspection. A courier can complete GDP training and work in line with the wholesaler's agreements.
• Does GDP say at which temperature medicines must be transported? No. The limit is on the pack or comes from the manufacturer; the guidelines require transport to stay within it.
• Is GDP the same as GMP? No. GMP covers the manufacturing of medicines, GDP the wholesale distribution afterwards.

If you ask a carrier about GDP, do not ask for a certificate but for the arrangements: which condition, how it is measured, how and to whom a deviation is reported, to whom the shipment is delivered, and what you get to see afterwards. That is what a wholesaler has to ask of its carrier under chapters 7 and 9, and what a pharmacy can just as well ask.

UrgentX Transport is a carrier without a wholesale distribution authorisation and therefore has no GDP certificate; we do not claim one either. The driver completed GDP training for transport, and our way of working is built around the transport-related parts of chapter 9: the condition you or the manufacturer prescribe, measurement at pickup and delivery, reporting of deviations and delivery to the addressee. What that means for your shipments in concrete terms is described under transporting medicines in line with GDP.