TARGET SUCCESFULLY REACHED

The combined teams of MADO SYSTEMY and LEK-AM companies developed as a project team, a comprehensive implementation of serialization of medical products in accordance with the requirements of the EU Falsified Medicines Directive (FMD) on four production lines in a modern production plant of LEK-AM.

A project of this scale required a partner who had experience in managing the risks associated with implementing the new serialization processes. Production companies, regardless of their size, put more and more emphasis on production efficiency and the best possible use of the machine park. Maintaining a high OEE index while implementing a new technology requires close cooperation between the supplier and the manufacturer. Mado Systemy from Gdańsk was chosen for this project.

A dedicated team of qualified engineers was able to carry out a large part of the implementation work remotely, ensuring significant cost and time savings. They spent the consultation period with the client on carrying out independent test projects which were later used for the quick and smooth execution of the order. This resulted in the delivery of a complete solution both on time and in line with the assumed budget.

The entire project was also carried out in accordance with the philosophy of the Open SCS Group, which enables further integration and development of additional functionalities (e.g. in the case of aggregation) without putting the customer in a “vendor lock-in” situation – dependence on one supplier.

Comprehensive implementation of the serialization project included:

1. Implementation of the necessary Verifarma software, which is responsible for:
• Generating serial numbers for Lek-Am’s own production.
• Generating and sending serial numbers to CMO.
• Receiving CMO-produced serial numbers for Lek-Am.
• Communication with EMVS for serial number status reporting, recall and changes.
• Managing the database of manufactured serial numbers.
• Reporting of serial number transactions Reporting of production operations and storage of operation history.
• Communication and management of own production, sending and receiving orders from production lines GMP compliant event log.

2. Implementation of four TQS-HC-A devices from WIPOTEC-OCS
• They work automatically with a throughput of up to 300 pieces / minute
• Managing serialization orders at the production line level
• Integrated system for weighing, printing serialization data, applying tamper-evident labels and verification of all above.

The process of an end-to-end serialization solution described above actually works so that for in-house production at Lek-Am, serial numbers are generated in the Verifarma system for the created orders. After generating the appropriate data, it is sent to the TQS serialization lines. Processed orders are stored locally in the machine database. The operator selects the right order and starts production. After its completion and confirmation of completion in the TQS machine, the order is automatically sent to the Verifarma system, where in the next step the responsible person decides to release the batch for trade. After being released in the Verifarma system, the order is reported to the EMVS.

“It was with great pleasure that we worked with competent and committed employees of Mado on this project. The solution is user-friendly, employees and operators praise the after-sales support, as well as the work in production. Our success in implementing the serialization process without any delays in the execution of production plans, without creating additional stock, would not be possible without the full commitment of Mado employees”
– Piotr Malanowicz said, Director of the LEK-AM Sp. z o.o.

ABOUT LEK-AM

The Pharmaceutical Company LEK-AM Sp. z o.o. is one of the most dynamically developing pharmaceutical companies on the Polish market. Currently, the company employs over 440 people, and this number is gradually increasing. The company’s production plant is located in Zakroczym near Warsaw. The production facilities are a modern pharmaceutical production plant and a laboratory equipped with the highest quality equipment. Production lines and the laboratory operate according to European standards, and a team of qualified and professional employees ensures that they are complied with. The preparation methods meet all GMP requirements, and the products for clinical trials are manufactured in accordance with GLP and GMP guidelines. Even today, when planning the production of further preparations, they are gradually implementing the next stages of expanding the production facilities along with the necessary technological solutions for serialization in order to ensure the highest quality, safety, and authenticity of their products.

ABOUT MADO

Mado Systemy specializes in comprehensive services related to the proper functioning of quality control in the production process for the food, pharmaceutical and cosmetic, chemical, transport and logistics industries. Mado is a family company with 25 years of experience, many projects, also “tailor-made”. They support pharmaceutical companies in the design, installation, integration, and implementation of technologies as well as serialization and aggregation processes.