Good Distribution Practice (GDP)

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 G ood 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