Safety is our top priority and Orifarm meets all legal standards set by the authorities.
Parallel imported and generic pharmaceuticals are as safe as the equivalent original pharmaceuticals and Orifarm is liable to the same strict quality and safety requirements as the original manufacturer. We check the products carefully and make sure that the quality of the products is maintained from manufacturer to supplier to end-user.
Orifarm is approved as a company for parallel import of pharmaceuticals by the responsible authorities and holds relevant manufacturer and distribution licenses, which entitles us to repack and distribute pharmaceuticals. We are liable to the same strict quality and safety requirements as the original manufacturer of pharmaceuticals. Compliance with these requirements is closely monitored by national and European institutions, such as the European Medicines Agency (EMA).
Orifarm exclusively collaborates with wholesalers in EU countries, all of whom have a valid wholesaler license and a quality system in accordance with the current Good Distribution Practice (GDP) guidelines. In this context, our suppliers are regularly audited by their locally responsible health authorities. Additionally, Orifarm has its own supplier qualification system, which sets high standards in operational processes as well as quality and is continuously enhanced.
In a multi-level quality control process, we then check every step that a product passes through to ensure safety and quality.
1. and 2. Quality Control of Medical Products
Once the originators' pharmaceuticals from other European countries arrive at Orifarm premises, they are unloaded in a manner to prevent them from being exposed to sun, rain, or cold at any time. On all of our transport routes, the temperature is closely monitored. The medical products are counted and sorted. We take samples from each batch and review them based on a binding template, which is called "product specification". Only after passing all tests are the medical products released for production, which is then initiated by an order.
3. Repacking
This is when the actual repackaging process of the pharmaceuticals begins. We do not only leave that to machines, but to our experienced and continuously trained staff. In this production step, every package is provided with a patient information leaflet and with either a label or a new folding box according to the specification and the sales countries' requirements.
4. Quality Control of Finished Products
Our Quality Control staff take packs from every batch and examine them very carefully by using the product specifications (see step 1) as a reference. After passing all tests, the finished goods are moved to highly qualified and officially approved staff ("Qualified Person"), who verifies that all our operations have been performed in accordance with GMP and GDP standards. Only then are the pharmaceuticals released for shipment to our consumers.
5. Delivery to Wholesalers and Pharmacies
After we have made all the necessary quality control checks and released the product, the pharmaceuticals are then distributed to wholesalers and pharmacies, ready for sale.
A very large part of the pharmaceuticals sold today are, in fact, generic products. This generates large savings for both consumers and society.
Generic pharmaceuticals are subject to the same strict regulations and high quality standards as the original products. The active ingredient in a generic product is identical to the active ingredient in the original product.
At Orifarm, we deal with approved contract manufacturers from all over the world. These manufacturers produce pharmaceuticals, which we market in Scandinavia. In order to release and distribute these products, we have acquired a manufacturing license from the responsible authorities. As a pharmaceutical company, we follow the EU rules and regulations called Good Manufacturing Practice (GMP) and Good Distribution Practice (GDP). Through our strict quality control, we make sure that each of our contract manufacturers complies with the GMP and that all products are tested within the EU.
The following steps are essential in ensuring a high quality standard for our generic pharmaceuticals.
1. Qualified and Approved Contract Manufacturer
Orifarm cooperates with contract manufacturers from all over the world that have been approved by an EU authority and Orifarm in accordance with the most current GMP. Through our strict quality control, we make sure that each of our contract manufacturers lives up to GMP.
2. Manufacturing of Medical Products
According to GMP, the pharmaceuticals are manufactured under constant control by Orifarm. All production facilities are frequently inspected by Orifarm and by an EU authority to ensure a constant safety and quality standard.
3. Analytical Tests of Finished Products
Once the pharmaceuticals are manufactured, analytical tests are performed within the EU. Through our strict quality control, we make sure that each of our contract test laboratories lives up to GMP.
4. Quality Control and Release of Finished Product
When the pharmaceuticals arrive at Orifarm, we again perform quality control checks to be able to release the product. In order to release and distribute the products, we have acquired a manufacturing license from the responsible authorities.
Orifarm ensures that there is a continuous quality control check through each step, as seen in the illustration above.
5. Delivery to Wholesalers and Pharmacies
After we have made all the necessary quality control checks and released the product, the pharmaceuticals are then distributed to wholesalers and pharmacies, ready for sale.
