GDP supervision

The Dutch Health and Youth Care Inspectorate (IGJ) monitors the entire distribution chain for medicinal products. If the quality of the medicinal products in the distribution chain from manufacturer to patient is to be guaranteed, manufacturers and wholesalers must comply with the stricter rules for Good Distribution Practices (GDP).

Medicinal products in the Netherlands nowadays come from all over the world, with all the concomitant risks. The GDP norm was amended in 2013 as a result. This new norm, which is replacing the GDP standard from 1994, imposes additional requirements on the logistics of medicinal products and also gives more guarantees that the medicinal products that the patients use are of good quality. More information about the precise changes is given in ‘Vragen over de EU-richtsnoer goede distributiepraktijken (GDP)’ (Questions about the EU GDP guideline, in Dutch).

Representatives and staff of pharmaceutical and logistics companies discussed the norm at a congress on 2 September 2013.Read the congress report here.

Inspections

The IGJ carries out periodic inspections at all medicinal product distributors and importers in the Netherlands. During those inspections, which sometimes take several days, the IGJ checks whether distributors and importers are complying with the GDP guidelines. The IGJ will be busy until 2018 carrying out a round of inspections at all pharmaceutical companies to inspect them against the new norm.

For the manufacturers, a GDP inspection is generally combined with a GMP inspection.