Oldenburger|Fritom is GDP-API registered

Oldenburger|Fritom is the first logistics service provider in the Northern Netherlands to be GDP-API registered. This means we are authorized to store and distribute active ingredients of medicines for which the registration has been issued. The registration shows that we maintain the quality of these substances in the supply chain.

In line with the Lean Six Sigma method, which is the common theme throughout our business operations, we focus on continuous improvement. We do this by proactively and continuously responding to developments in the market, often in cooperation with our customers. For example, earlier this year we were approached by one of our customers in Veendam, who is expanding its services with the import of active ingredients for medicines from Asia. This customer asked us to take care of the warehousing, value added services and distribution of these substances. This requires an API registration.

GDP-API registration
The active substance in medicines is called Active Pharmaceutical Ingredient (API). To ensure that the quality of active ingredients of medicines is maintained from manufacturer to user, importers and distributors of these substances must be GDP-API registered. This demonstrates that they meet the requirements of the GDP (Good Distribution Practice) guidelines. In addition, all parties in the supply chain share responsibility and monitor each other.

In the Netherlands, the EU guidelines on Good Distribution Practice fall under the supervision of the Health and Youth Care Inspectorate (IGJ). The guidelines state that a distributor of medicines guarantees that the quality during distribution is maintained for the users. This is guaranteed, among other things, through strict regulations regarding the logistics and distribution of medicines. If a distributor is not GDP-API registered, it is not legal to trade in medicines in the European Economic Area (EEA).

Responsible Person (RP)
All our employees involved in the logistics and distribution of active ingredients of medicines have successfully completed the required API training. This means they have the responsibility to report problems related to medicine safety to the Responsible Person (RP). The Responsible Person has completed a specific training course and carries out duties in such a way that the distributor can demonstrate GDP compliance. We have designated both our Continuous Improvement Manager and our QHSE Manager as Responsible Person.

Healthcare Logistics
Oldenburger|Fritom is the first logistics service provider in the Northern Netherlands to be GDP-API registered. We previously obtained the ISO 13485 certificate for medical devices. As with our ISO 13485 certification, we want to add value to the supply chain of our customers in the healthcare sector with the GDP-API registration.