GDP training or GDP certificate? The difference, and what a carrier can and cannot claim

GDP stands for Good Distribution Practice: the European guidelines on good distribution practice of medicinal products for human use (2013/C 343/01). They describe the minimum requirements a wholesaler has to meet to preserve the quality and integrity of medicines along the distribution chain, and they also cover storage conditions during transport.

They become binding through legislation. The European medicines directive (2001/83/EC) obliges holders of a wholesale distribution authorisation to comply with the GDP principles and guidelines. In the Netherlands this is laid down in the Medicines Act: wholesale distribution requires an authorisation, and the wholesaler has to make sure that purchasing, storage and supply follow the designated GDP rules. The accompanying ministerial regulation designates the European guidelines for that purpose. Supervision lies with the IGJ.

The guidelines are addressed to the wholesaler throughout. A carrier is not an addressee in its own right, but the introduction does ask other parties in the chain to comply with the parts relevant to them. How that works in practice is explained further down. A fuller explanation of the guidelines and of chapter 9 is in GDP and transport; what GDP is exactly and who it applies to, in plain language, in what is GDP.

GDP training is education: a course in which people learn what the guidelines require, for instance on temperature control, documentation, hygiene or handling deviations. The guidelines themselves impose training as a duty on the wholesaler. All personnel involved in wholesale distribution activities must be trained, initially and on an ongoing basis, with specific training for those who handle temperature-sensitive products. Training is recorded and its effectiveness is assessed periodically. Chapter 9 returns to training for the staff who assemble insulated boxes, adjusted to the season.

Proof of attendance at such a course therefore says something about the knowledge of a person or a team at a given moment. It says nothing about an inspection of the company, and it is not a document issued by a supervisory authority. Nor do the guidelines name a recognised or mandatory training certificate; the requirement is that training takes place, is recorded and works.

For a carrier, training runs through the wholesaler that hires it. The wholesaler has to satisfy itself that the work is done in line with GDP and sets out in the agreement what is expected of the carrier. A carrier that has its people trained makes that conversation easier. It does not become certified by it.

The medicines directive arranges it like this: manufacturers and wholesalers are inspected repeatedly by the competent authority. If an inspection shows that a wholesaler complies with the GDP principles and guidelines, the authority issues a GDP certificate to the inspected entity within ninety days. Certificates and statements of non-compliance are entered in EudraGMDP, the publicly accessible Union database.

The IGJ says the same from Dutch practice: a GDP certificate is only issued after a wholesale distribution authorisation has been granted and the inspectorate has established that the wholesale activities were demonstrably carried out in line with GDP. A certificate is valid for at most five years. The European procedure for issuing certificates adds that a certificate confirms the outcome of an inspection at a given moment and is not extended; a subsequent inspection leads to a new certificate.

The IGJ inspects applicants for an authorisation and, on a risk basis, existing holders. Carriers and couriers are not named as an object of inspection on the inspectorate's supervision page. That matches the law: the certificate is tied to the authorisation and to the inspection of a wholesaler.

Usually not. The Dutch Medicines Act describes wholesale distribution as purchasing, holding in stock, supplying or exporting medicines prepared or imported by others. Transport is not in that list, and the European definition does not name transport as such either. An authorisation is needed by those who procure and supply medicines, as Farmatec, which issues the authorisations on behalf of the minister, also explains.

The IGJ has made the boundary concrete for carriers. A company that only transports medicines and holds them at a location for less than 72 hours, for example during transhipment, does not need a wholesale distribution authorisation. A carrier that structurally stores medicines for 72 hours or longer is, in the inspectorate's view, a contract wholesaler and does need one. In both cases the GDP rules on personnel, storage and transport have to be observed, and the client oversees this through audits and a written agreement. The 72-hour limit is not in the law; it is supervisory policy, and policy can change.

The consequence for the certificate is simple. No authorisation means no inspection as a wholesaler, and so no GDP certificate. Not because the carrier is doing something wrong, but because the certificate does not exist for it.

Put the two concepts side by side. A GDP certificate: issued by a supervisory authority, after an inspection, to a wholesaler with an authorisation, findable in EudraGMDP, valid until the next inspection. A training certificate: issued by a course provider, to a person, as proof of attendance or of a passed test. Anyone who writes after a course that the company is GDP-certified is mixing up the two.

That does not make the claim untrue in every case. A carrier that also stores medicines and holds a wholesale distribution authorisation for that can have a certificate after an inspection. So it is a question to ask, not a reason to dismiss anyone: which document is it, who issued it, to whom, and when? If the party is in EudraGMDP, it is a certificate within the meaning of the directive. If it is not, it is something else, however neatly it has been laid out.

A quality department assessing a carrier does get something out of a training record, by the way: it is one of the things chapters 2 and 9 ask of the wholesaler. The answer to the question 'are you GDP-certified?' should then be: no, and this is what we do have and do.

GDP reaches the carrier through two chapters. Chapter 7 deals with outsourced activities: there is a written contract with a clear division of tasks, the client remains responsible, it may audit before the start and at any time afterwards, and the contractor may not subcontract anything without approval. Chapter 9 deals with transport and places the responsibility for protection against breakage, falsification and theft, and for keeping the temperature within acceptable limits, with the supplying wholesaler, even when a third party drives. The contract with that third party must then include the requirements of chapter 7, and the wholesaler informs the carrier of the transport conditions.

In concrete terms chapter 9 asks, among other things: storage conditions during transport within the limits set by the manufacturer or shown on the outer packaging; deviations reported to the distributor and the recipient and investigated; a risk assessment of the route to determine where temperature control is needed; measuring equipment calibrated at least once a year; delivery to the addressee at the address on the delivery note. The IGJ adds that a wholesaler or manufacturer cannot transfer the responsibility for transport to the carrier by contract. Making and recording arrangements is allowed, and required.

So a ride with medicines does fall under GDP, without the carrier holding a certificate. The carrier works under the wholesaler's agreement and audits; the wholesaler remains responsible. How that division of roles works exactly and what belongs in the contract is explained in GDP responsibilities in outsourced transport. What should happen in the event of a deviation is explained in temperature excursion during transport.

A pharmacy, wholesaler or hospital assessing a carrier can use the guidelines as a checklist. Not to demand a certificate that cannot exist, but to see whether the work is demonstrably done by the rules.

If a carrier claims to be GDP-certified, ask for the certificate and look the party up in EudraGMDP.

• Which GDP training have the drivers completed, when, with whom, and how is it kept up to date?
• Is there a written agreement with a division of tasks, and may you audit before the first ride and afterwards?
• How is temperature controlled and recorded, with which equipment, and when was it last calibrated?
• How and to whom is a deviation reported, and what happens to the shipment until you have decided?
• Is delivery made to the addressee at the address on the delivery note, with proof of who signed and when?
• Is anything subcontracted, and if so to whom, and with your approval?

UrgentX Transport is a carrier without a wholesale distribution authorisation and therefore has no GDP certificate; we do not claim one. What is true: the driver has completed GDP training for transport, our way of working is built around the transport-related parts of chapter 9 (agreed condition, measurement at pickup and delivery, reporting of deviations, delivery to the addressee), and your quality department can audit us. What that looks like in practice is described under transporting medicines in line with GDP and in the answers on quality and compliance.