How it is evidenced
Audit and qualification as a GDP transport supplier
GDP requires distributors to qualify whoever they subcontract transport to. Here, up front, is what that qualification receives, so the process does not consume three weeks of emails.
Why does the carrier have to be qualified?
Because Chapter 7 of GDP guidelines 2013/C 343/01 makes the distributor accountable for outsourced activities. Subcontracting transport does not transfer responsibility: it requires assessing the contractor’s competence, setting out in a contract what each party does, and monitoring it afterwards. That is why a pharmaceutical customer cannot simply buy transport on price, even if it wanted to.
What documentation is provided?
The full dossier is sent on request, with no need for a prior visit. It contains:
- Current certificates
- GDP · ATP-FRC · ISO 9001:2015 · TAPA TSR1 · Registro Sanitario 40.055673/B, with their scope and dates. The GDP certificate is issued by AENOR and the TAPA TSR1 one by Bureau Veritas.
- Quality system procedures
- Pre-cooling, loading, in-transit temperature control, incident handling, delivery and deviation management.
- Thermal mapping reports
- For the vehicles assigned to the lane. See qualification and mapping.
- Probe verification records
- Evidence that the readings in the record are reliable.
- Training plan
- Training for staff handling pharmaceutical product, with its records.
- Liability insurance
- Transport cover, with its limits per shipment.
- Supplier questionnaire
- The customer’s own questionnaire is completed in its own format, which is what their system expects to file.
Are on-site audits accepted?
Yes, at the operating base in Carrer Llevant 21, 08495 Fogars de la Selva (Barcelona, Spain). An on-site audit shows what a dossier cannot: the real condition of the fleet, how a pre-cooling is done, how a door opening is logged and how an incident is documented from the traffic desk. Dates are agreed in advance so the people and vehicles the auditor wants to see are available.
What does a GDP audit usually ask a carrier?
- Where the control probe is and which mapping report justifies that position.
- How an excursion is detected and how quickly it reaches the customer.
- What happens if the cooling unit fails en route, and who decides what to do.
- Who is allowed to drive a pharmaceutical service and what training is on record.
- How long records are kept and how they are retrieved two years later.
- Whether work is subcontracted to third parties, and on what terms.
The first three are answered in thermal mapping, temperature excursions and temperature records. On the last one: fleet and drivers are in-house, which is what makes it possible to answer the other five with evidence rather than with a third party’s promise.
Frequently asked questions
How long does the dossier take?
It goes out as soon as it is requested. Just ask at trafico@coolcargo.es, stating the legal entity carrying out the qualification and, if there is one, attaching your own questionnaire so it comes back completed in your format.
Does a technical quality agreement have to be signed?
Yes, and it is both normal and advisable. A technical or Quality Agreement sets out in writing what each party does: ranges, deadlines for reporting deviations, record retention and the contact channel. It is what Chapter 7 expects to find, and it prevents arguments on the day something goes wrong.
Is an audit by a consultancy on the customer’s behalf accepted?
Yes, on the same terms as a direct audit: dates and scope agreed in advance, and confirmation that it is acting on the customer’s behalf.
Need a full truck for pharmaceutical or refrigerated freight?
Tell us origin, destination, temperature range, product type and volume. A dedicated account manager comes back with a firm quote within one working day. If it is urgent, call.