Quality management

Hygiene turnstile and manufacturing specifications

To ensure compliance with hygiene regulations, a hygiene turnstile is the only access to the EurimPharm production area. Additional stringent requirements in the production area ensure the safe production of our pharmaceutical products.

Each imported pharmaceutical is repackaged by EurimPharm with entirely German-language information, as required under the German Pharmaceuticals Act.

Detailed procedures for production are established which also visually outline the re-packaging process and precisely describe how the production must be carried out. The EurimPharm production management establishes new manufacturing processes with each variation of a product.

During the manufacturing process, each product receives its own serial number (data matrix code) as well as a EurimPharm-specific lot number that is assigned upon preparation of goods for the production. This allows tracing the flow of goods of each individual package throughout the entire process.

Safety requires constant monitoring

... in order to reliably exclude falsifications and sub-standard quality of the products.

Imported pharmaceuticals by EurimPharm are subject to the neutral supervisory body of the Federal Institute for Drugs and Medical Devices (BfArM) as well as our production and control system according to PIC and GMP. Each incoming delivery is checked for its identity based on the delivery documents. Lot number, expiry date, lot consistency, appearance of packaging, quantity - everything must match. In addition, the declaration of the pharmaceutical product is checked and in-process controls monitor the packaging process. Each individual step is checked and monitored by the subsequent step. The final inspection is responsible for the marketing release authorization by an internal independent body.

State-of-the-art technology for constant temperature control

The pharmaceuticals are transported by carefully selected logistic contractors. Our ISO-certified transport partners operate with detailed temperature records. A well-defined and strictly monitored quality assurance system establishes the highest safety standards here, too.

All pharmaceuticals are transported in actively cooled vehicles. Temperature-sensitive goods are continuously monitored on route to EurimPharm. A so-called "thermologger," a type of black box, regularly measures the temperature during transport. In addition, the temperature is also measured by the independent vehicle system. Upon arrival, the sensor memory is analyzed via a monitor. As a result, the head of quality control can see at a glance whether the required transport temperature was observed. The risk of an improperly transported pharmaceutical slipping through the tight network of our quality assurance procedures is therefore eliminated.