High Quality Standards

Safety is our top priority and Orifarm meets all the legal standards set by the national and EU authorities. Parallel imported and generic pharmaceuticals are as safe as the equivalent original products and Orifarm is liable to the same strict quality and safety requirements as the original manufacturer of pharmaceuticals. We check the products carefully and make sure the quality of the products is maintained from manufacturer to supplier to end-user.

Please read below to learn more about our quality processes within parallel import and generics.

Quality Parallel Import

Orifarm is approved as a company for parallel import of pharmaceuticals by the responsible authorities and holds a manufacturer and distribution license, which entitles us to repackaging and distribution of 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 works together with wholesalers in EU countries, of which all have a valid wholesaler license and a quality system in accordance with the most current Good Distribution Practice (GDP) guidelines. In this context, our suppliers are regularly audited by their locally responsible authorities. In addition, Orifarm has its own supplier qualification system, which sets high standards in operational processes as well as quality and which is continously being enhanced by us. 

In a multi-level quality control process, we then check every step that a product passes in order to ensure safety and quality:

1. & 2. Quality control of medical product
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 temperature is closely monitored. The medical products are counted and sorted. We take samples from each batch and review them on the basis of a binding template which is called "product specification". Only after passing all tests, the medical products are released for production which is then initiated by an order.

3. Repacking 
This is when the actual repackaging process of the pharmaceuticals begins. We don't 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 the pharmaceuticals are released for shipment to our customers.

5. Delivery to Wholesalers & Pharmacies
After we have made all the necessary quality control checks and released the product, the pharmaceuticals are then distributed to the wholesalers and pharmacies, ready for sale.

Quality Generics

A very large part of the pharmaceuticals sold today are in fact generic products. This generates large savings for both patients and society.

Generic pharmaceuticals are subject to the same strict regulation 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 Generics 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 manufacturer lives up to the GMP and all products are tested within the EU.

The following steps are essential in ensuring a high quality standard on 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 Generics according to most current GMP. Through our strict quality control, we make sure that each of our contract manufacturer lives up to GMP.

2. Manufacturing of Medical Product
According to GMP the pharmaceuticals are manufactured under constant control by Orifarm Generics. 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 made within the EU. Through our strict quality control, we make sure that each of our contract test laboratories live up to GMP.

4. Quality Control and Release of Finished Product
When the pharmaceuticals arrive at Orifarm Generics we again make 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 Generics ensures that there is a continuous quality control check through each step as seen in the illustration above.

5. Delivery to Wholesalers & Pharmacies
After we have made all the necessary quality control checks and released the product, the pharmaceuticals are then distributed to the wholesalers and pharmacies, ready for sale.