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GDP: Good Distribution Practice 


Good Distribution Practice (GDP)

According to the EMA, Good Distribution Practice (GDP) comprises minimum standards that a wholesale distributor should meet to ensure that the quality and integrity of medicines are maintained over the supply chain.

Compliance with Good Distribution Practices for pharmaceutical products ensure that:

  • medicines in the supply chain are authorized in line with European Union (EU) legislation;

  • medicines are maintained in the right conditions at all times, including during transportation; contamination by or of other products is avoided;

  • an adequate turnover of stored medicines takes place;

  • the right products reach the right recipient within a satisfactory time period.


The GDP term is included in World Health Organization WHO’s Technical Report Series Annex 5 - Good distribution practices for pharmaceutical products. Good Distribution Practice (GDP) is defined in this guideline, as follows;


Quality assurance should ensure the quality of a pharmaceutical product is maintained by means of acceptable controls of the multiple activities which happen during the distribution process as well as providing a tool to guarantee the distribution system from counterfeits, unapproved, illegally imported, stolen, substandard, adulterated, and/or misbranded pharmaceutical products. The guideline consists of the subtitles below.

    1.  General principles
    2.  Regulation of the distribution of pharmaceutical products
    3.  Organization and management
    4.  Personnel
    5.  Quality system
    6.  Premises, warehousing, and storage
    7.  Vehicles and equipment
    8.  Shipment containers and container labeling
    9.  Dispatch and receipt
    10.  Transportation and products in transit
    11.  Documentation
    12.  Repackaging and relabelling
    13.  Complaints
    14. Recalls
    15.  Returned products
    16. Counterfeit pharmaceutical products
    17. Importation
    18. Contract activities
    19.  Self-inspection
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