From the very beginning the production and logistics buildings were planned to meet the requirements of a superordinate goods flow concept. The allocation of space and the size of the buildings were each optimally tuned to the demands of the other. Every pharmaceutical substance has a precise position in the production process. At the front of the production area there is a main hygiene sluice every production worker is expected to go through. There are four spatially connected, cooled facilities available for substances that must be kept cool. This guarantees seamless refrigeration for temperature-critical goods. Temperature-critical pharmaceutical substances work their way through all the stations in this way, from receipt to storage and on to dispatching. The goods are repeatedly checked, at the end of each working step inspected and only sent on to the subsequent step if approved. All entries, movements and departures of items at EurimPharm can be tracked and traced via a validated storage administration system and packaging verification.
EurimPharm Produktions GmbH offers customers 40 years of experience in the packaging of pharmaceutical products and customised solutions in the secondary packaging of pharmaceuticals.
Based on the manufacturing licence stipulations, EurimPharm provides the following packaging solutions for pharmaceuticals (standard goods, refrigerated goods, anaesthetics) or medical products:
- Change of pack sizes
- Labelling of blisters
- Automated labelling
- Labelling of inner and outer packs
- Replacement of instruction leaflet
- Complete new secondary packaging
All the necessary steps are conducted according to GMP conditions.
EurimPharm Produktions GmbH service provision also benefits from the unique wealth of experience offered by its employees. This enables the business to react to customer requests at any time. The following services are provided in-house to ensure customers benefit from affordable solutions, even for the smallest of orders:
- Design of instruction leaflet
- Design of all required labels
- Design of folding boxes according to customer specifications
- Printing and creasing of instruction leaflet
- Label printing
The EU-Directive for protection against Falsified Medicines (FMD) demands comprehensive measures by pharmaceutical enterprises to ensure the verification of Rx-medicinal products. A manufacturer has to produce an individual serial number for every single package. This must be printed on the packaging along with the GTIN or NTIN, serial number, lot number and expiry date in human readable format as well in a data matrix code. The data has to be uploaded onto the European database and the requisite booking out administration steps completed, as is the case with with deductions and returns. Another sign of safety and security companies are required to show is the sealing label designed to make it more difficult to exchange the contents.
Already now we have the relevant technologies to fulfill all requirements of the EU-Directive for protection against falsified medicines.
- Generation, administration and verification of randomised serial numbers
- Application of a 2D-barcode and its readable contents on the secondary packaging
- Generation of ready-made files for reporting to securPharm or EU hub
- Administration of applicable data and its status for each individual pack
- Application of tamper-proof evidence seals on the secondary packaging
Advice on the implementation of FMD
As a participant in securPharm and member of the EMVO (European Medicines Verification Organisation) EurimPharm Produktions GmbH has many years of experience in the implementation of regulations. We have established a network of partners that can manage hard and software projects and guarantee implementation at the customer’s base.
We work together with a carefully selected machine builder and serialisation specialist to provide customers with the necessary validatable soft and hardware, and project management is extremely professional and efficient.
At any time EurimPharm Produktions GmbH can of course take on the tasks of secondary packaging, including all the necessary serialisation steps, as a service for customers with a limited portfolio of prescription drugs (Rx), or whose investment in hard and software was not made by the required implementation date.
IT and reporting
Modern IT structures ensure all data can be managed redundantly and saved every day.
Our modern ERP and logistics software ensure every single step of the process is documented – from the receipt of goods to release. Furthermore, the recently implemented serialisation software means that, as well as tracking and tracing batches, the customer can also discover the status of every single pharmaceutical package – regardless of whether it is on the serialisation line, the production task has been completed or it is in the process of being uploaded onto a domestic or European database. Our data warehouse enables us to provide customer-specific information.
Transportation of pharmaceutical products can only be carried out by a small selection of validated forwarding agents. ISO-certified transport businesses provide detailed chronological temperature records. A precisely defined, rigorously implemented quality assurance system sets the very highest safety standards.
All pharmaceuticals are transported in actively cooled vehicles. Temperature-critical goods are monitored continually during transportation using a ‘thermologger’ – a kind of black box that measures the temperature regularly during transportation. In addition, the temperature is also measured by the transporting vehicle. On arrival, the sensor readings are taken from the memory and evaluated graphically on a monitor. This enables quality control managers to see – at a glance – whether the stipulated transport temperatures have been maintained throughout the journey. This enables EurimPharm Produktions GmbH to guarantee goods are stored and transported in perfect condition on the way from the customer to us and on the way back.
EurimPharm Produktions GmbH benefits from the latest room monitoring technology to offer customers storage facility services under the following conditions:
- Temperature-controlled areas for standard goods
- Refrigerated areas between 2°C – 8°C for temperature-critical refrigerated goods
- Secure areas for anaesthetics and controlled substances
At any time the customer can request and review chronological temperature records for the relevant areas of a storage facility. Every movement of goods into, within and out of storage areas, can be tracked and confirmed using computer-aided logistics software.
Hygiene sluices and manufacturing regulations
Access to the production area is only possible via a hygiene sluice at EurimPharm Produktions GmbH to ensure compliance with all hygiene regulations. In the plant itself further strict guidelines guarantee safe and secure packaging of all pharmaceuticals.
Detailed instructions are devised for each production run to provide a graphic representation of the packaging process and exact information on how to manufacture required goods. Production management adapts the manufacturing instructions in accordance with any changes the customer may make.
No security without scrutiny
Control steps are conducted to monitor the different packaging procedures. Every item leaving one station is checked and tested at the next station.
The final inspection is conducted independently before products are approved for general circulation. The employees responsible report directly to their AMG supervisors.
The Upper Bavaria Supervisory Authority has approved our GMP and GDP compliance for the pharmaceutical sector.
Continual internal and external auditing guarantees seamless monitoring of processes and enables them to be adjusted and developed to suit all the latest customer requirements without delay.