Testing, certification and training services
Centralny Ośrodek Chłodnictwa w Krakowie COCHCentralny Ośrodek Chłodnictwa w Krakowie COCHCentralny Ośrodek Chłodnictwa w Krakowie COCH
+48 503 021 131
30-133 Cracow, Poland
Centralny Ośrodek Chłodnictwa w Krakowie COCHCentralny Ośrodek Chłodnictwa w Krakowie COCHCentralny Ośrodek Chłodnictwa w Krakowie COCH

Good Distribution Practice (GDP)

Good Distribution Practice GDP – general information

Our company offers a reliable assessment of refrigerated transport equipment for Good Distribution Practices in the EU known as Good Distribution Practice - GDP.

Good Distribution Practices (GDP) certification requires that those who handle pharmaceutical products meet stringent World Health Organization (WHO) standards for safety and security. Although GDP certification is not a global requirement, EU pharmaceutical companies and their logistics partners must comply with GDP regulations.

The requirements (EU GDP) define the conditions necessary to meet in order to obtain Good Distribution Practice certification for means of transport (vehicles) intended for the transportation and storage of sensitive products (temperature-sensitive products), including medicines. Taking into account the requirements of the regulations - only refrigerated means of transport as vehicles with reinforced insulation are able to meet them, guaranteeing the safety and quality of transported products. The term "refrigerated means of transport" includes means of transport with non-mechanical and mechanical cooling intended for the transportation and storage of temperature-sensitive products (e.g., perishable food products, medicines) certified by ATP, whose body with a built-in, insulated cargo compartment, is directly and permanently mounted on the vehicle chassis / trailer.  A certificate (EU GDP) can be issued for a means of transport (vehicle) that has a current ATP certificate and meets certain legal and normative requirements.

Good Distribution Practice (GDP) describes the minimum standards that a wholesaler must meet to ensure that the quality and integrity of medicines are maintained throughout the supply chain.

Compliance with GDP ensures that:

- drugs in the supply chain are authorized in accordance with European Union (EU) legislation;
- drugs are always stored in the right conditions, including during transport;
- contamination with other products is avoided;
- there is an appropriate marketing of stored medicines;
- the right products reach the right addressee in a satisfactory timeframe.


The distributor must also put in place a tracking system so that defective products can be found and an effective recall procedure can be implemented.

GDP also applies to the acquisition, storage and transportation of active pharmaceutical ingredients and other components used in the manufacture of drugs..

Useful links:

https://ec.europa.eu/health/human-use/good_manufacturing_distribution_practices_en

https://www.ema.europa.eu/en/human-regulatory/post-authorisation/compliance/good-distribution-practice

PR-06 Good Distribution Practice certification scheme, implemented at COCH, specifies the conditions necessary to obtain the relevant certificate (EU GDP) for means of transport (vehicles) intended for the transportation and storage of sensitive products (temperature-sensitive products), including drugs, for compliance with the requirements of normative document WTP - 01/2015 COCH - Requirements for Good Distribution Practice for means of transport of sensitive products transported under controlled/regulated temperature.


The Central Refrigeration Center "COCH" in Krakow is an accredited certification body for products certification (accreditation of the Polish Centre for Accreditation No. AC 036), meeting the requirements of PN-EN ISO/IEC 17065 standard.

Obtaining a certificate (EU GDP) for a specific type/model of means of transport (vehicle) intended for the transportation and storage of sensitive products is available to any manufacturer/supplier that provides stable organizational and technical conditions for the production/supply of said means of transport with specific parameters confirmed by relevant tests.


The certificate can be issued for a means of transport (vehicle) that has a current ATP certificate and meets the requirements of the above document to the extent specified by the manufacturer/supplier in the application for certification.

gdp tlo

Documentation – useful information

Rejestr wydanych certyfikatów GDP

Below you can download the register of GDP certificates issued by the COCH Certification Department by year:

Contact details

Headquarters address

Centralny Ośrodek Chłodnictwa „COCH” w Krakowie
Juliusza Lea 116,
30-133 Kraków, Polska

Phone

+48 12 637 09 33 w. 204
+48 797 129 505
+48 503 021 131

E-mail