GDP

GDP

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

Compliance with GDP ensures that:

- medicines in the supply chain are authorized in accordance with Thailand legislation, regulations;

- medicines are time and temperature sensitive; storage in the right conditions at all times, including during transportation;

- avoidance of contamination by or of other products;

- an adequate turnover of stored medicines takes place;

- the right products reach the right addressee within a satisfactory time period.

The distributor should also put in place a tracing system to enable finding faulty products and an effective recall procedure.

GDP also applies to the sourcing, storage and transportation of active pharmaceutical ingredients and other ingredients used in the production of the medicines.



 Wholesale Distribution Authorization 

Anyone engaged in the activity of wholesale distribution of medicinal products in the Kingdom of Thailand must hold a Wholesale Distribution Authorization Certificate issued by the Thai FDA Food and Drug Administration of the Ministry of Public Health (the national competent authority) or the Provincial Public Health Office where they carry out these activities. The same national authority is responsible for inspecting the wholesale distributor.

Wholesale distributors must comply with GDP to obtain a Wholesale Distribution Authorization Certificate. They can ensure that they meet all their legal obligations by following the GDP guidelines.

It should be duly noted that Manufacturing authorization holders do not require a separate authorization to distribute products that are already subject to a manufacturing authorization.

Importers and distributors of active substances intended for the manufacture of medicines in the Kingdom are obliged to register with the relevant national competent authority and comply with the principles of GDP for active substances.