Good Distribution Practice (GDP)

Good Distribution Practice GDP

Good Distribution Practice (GDP) certification requires that people handling pharmaceutical products meet the stringent World Health Organization (WHO) standards for safety and security. While GDP certification is not a global requirement, EU pharmaceutical companies and their logistics partners must comply with GDP regulations.

The PR-06 certification program of Good Distribution Practices (GDP), implemented in COCH, defines the conditions necessary to obtain a relevant certificate (EU GDP) for means of transport (vehicles) intended for the transport and storage of sensitive products (products sensitive to temperature), including drugs, for compliance with the requirements of the normative document WTP – 01/2015 COCH – Requirements for Good Distribution Practice in relation to means of transport for sensitive products transported in controlled / regulated temperature.

Obtaining a certificate (EU GDP) for a specific type / model of a means of transport (vehicle) intended for the transport and storage of sensitive products is available to any manufacturer / supplier who ensures stable organizational and technical conditions for the production / delivery of the above-mentioned means of transport with specific parameters confirmed by appropriate tests .

The certificate may be issued for a means of transport (vehicle) that has a valid ATP certificate and meets the requirements of the above-mentioned document to the extent specified by the producer / supplier in the application for certification.

Refrigeration R&D Center “COCH” in Krakow is an accredited product certification body (accreditation of the Polish Center for Accreditation No. AC 036), meeting the requirements of the PN-EN ISO / IEC 17065 standard.

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


GDP compliance ensures that:

  • drugs in the supply chain are authorized in accordance with European Union (EU) legislation;
  • medicines are always stored in the right conditions, also during transport;
  • contamination with other products or other products is avoided;
  • the stored medicines are traded appropriately;
  • the right products reach the right addressee within a satisfactory time.

The distributor should also put in place a traceability system to find defective products and an effective recall procedure.

GDP also applies to the acquisition, storage and transport of active pharmaceutical ingredients and other ingredients used in the production 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

 
 

Contact

  • Refrigeration R&D Center in Krakow
    Juliusza Lea 116,
    30-133 Kraków, Poland
  • mgr inż. Małgorzata Wąs
  • +48 12 637 09 33 w. 204
    +48 797 129 505
    +48 503 021 131
  • certyfikacja@coch.pl

Documents

Register of issued certificates