Transport GDP

It is a compendium of regulations on good practices for the transport of medicines for human use included in the Guidelines of the European Commission, of November 5, 2013, on correct practices for the distribution of medicines for human use.

Condition maintenance

Most of the refrigeration units are autonomous, so they maintain the cold even if the truck is stopped. However, the word of the carrier is not enough, but the customer must be guaranteed that there have been no incidents of any kind.

To do this, temperature records are made with thermographs and calibrated probes, temperature mapping and records of stops or door openings, among others. In addition, a thorough cleaning must be carried out before loading medications, and it is recommended that vehicles intended for this use only be used for this purpose.

It is also important to be sure when you arrive at your destination that the medication has never been tampered with. To do this, some companies in the sector use cameras, alarms or special closing systems, so that no one is able to open the trucks under normal conditions and that if someone does, there is some kind of record.

Quality system

In short, it is necessary for the carrier to create a simple quality system, with an adequate documentary system, trained personnel, elements for risk management, and loading and unloading protocols, correction of temperature deviations, action in case theft or accident, etc.

Although carriers are not required to have a GDP good practice certificate, it is highly recommended and, in fact, the manufacturer and the laboratory may ask you to respect the points that apply to you. The objective is to do things the way customers like them, for whom it is mandatory, betting on a common structure and methodology in the sector.

Guarantees the integrity of the medicines you distribute

The GDP (Good Distribution Practice) certificate guarantees you to comply with all the correct practices for the distribution of medicines for human use, such as temperature monitoring and transport cleanliness and safety, in accordance with European directive 2013/C 343/01, approved in November 2013.

If you are a wholesale distributor, you can be sure that both exports and imports as well as the dispensing of pharmaceutical products to pharmacies are carried out in accordance with the law, thus avoiding defective products, fraud and counterfeiting that carry high fines.

Benefits granted by GDP certification

  • Prevents the marketing of counterfeit medicines
  • Prevents the distribution of medicines in poor condition
  • Protects against high penalties
  • Prepare to pass the relevant health inspections
  • Helps reduce deaths from defective drugs
  • Guarantees control of the entire supply chain

Why obtain GDP certification?

The increasing liberalization of the sale of medicines makes it more difficult today to trace pharmaceutical products from the manufacturer to the hands of the consumer. For this reason, it is essential to have a certificate that guarantees compliance with the Good Distribution Practices (GDP) implemented by the European Union.

This certificate will raise the image of commitment to health and legality of your company, conveying confidence to customers that your medicines meet all European standards and protecting you from the high fines provided by law.

Our contact details are as follows:

Address: Plaza de las Bandas de Música de la Comunidad Valenciana, 9 (46013)
mezzanine door 4, Valencia, Spain.

Phone: 607894968 – 639513248. TELF/FAX: 963301952

Hours: from 08:30 a.m. to 1:30 p.m. and from 3:00 p.m. to 6:00 p.m.

cmartinez@qualityadviser.com

qualityadviser@qualityadviser.com

cmazzuz@qualityadviser.com

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