Production Plant

The Production Plant

The production area including management, offices, purchasing, service departments and warehouses for active substances, packaging materials and finished products, are located in Trikala country 10 km from the Trikala town center. The plant is situated on 36000 m2 grounds, with the buildings constructed with reinforced concrete covering 14500 m2 of the total area.

Factory

Factory

VIOSER S.A is producing both medicinal products (terminally sterilized infusion and injection solutions, irrigation and urologic solutions) and medical devices (infusion and transfusion sets).

The production area including management, offices, sales, service departments and warehouses for active substances, packaging materials and finished products, are located in Trikala country 10 km from the Trikala town center.

The plant is situated on 36000 m2 grounds, with the buildings constructed with reinforced concrete covering 14500 m2 of the total area.

Technology

Technology

Production operation strictly follows clearly established and validated methods and procedures, which comply with the principles of Good Manufacturing Practice ‘’Manufacture of sterile products’’, in order to minimize the risks of microbiological, particulate and pyrogen contamination.

Each manufacturing stage is carried out in clean areas with the necessary environmental cleanliness grade. The equipment is designed for easier application of cleansing and sterilizing procedures, which cover all the necessary requirements. Facilities are continuously improved with the implementation of the latest technological achievements covering satisfactory the new GMP regulations.

The main equipment, which is used for the production of infusion solutions in round and oval bottles of various sizes, is based on the Blow/Fill/Seal Technology®.

We also use highly automated systems for the water treatment, distillation, solution preparation, sterilization and packaging.

Quality Control

Quality Control

QUALITY MANAGEMENT SYSTEM (QMS)

VIOSER’s Quality Management System ensures full compliance with the requirements of: ISO 9001:2008, EN ISO 13485:2012, c-GMP, c-GLP, c-GDP, WHO and the Updated Directive 93/42/EEC.

The Quality Management Department:

  • Maintains and implements the QMS
  • Schedules and carries out internal audits
  • Performs Product Quality Review
  • Manages customer complaints
  • Plans and performs Qualification of equipment and Validation of processes
  • Implements Change Control Procedure
  • Implements the procedure of Deviations handling as well as the corrective and preventive action procedure (CAPA’s)
  • Implements a Quality Risk Management (Risk Analysis/ Risk Assessment)
QUALITY POLICY

Vioser’s Quality Management System, including Top Management, determines and implements the Quality Policy. All quality related activities are carried out in a systematic and appropriate manner as reflected in Quality Management Manual.

Vioser continuously tries to produce the highest quality products and achieves profitable growth by pursuing excellence in all its aspects, with the active involvement of its staff, customers, suppliers and regulators. The commitment of all employees to Quality and improved performance is promoted by the Company through special training courses and encouragement of creative teamwork.

QUALITY CONTROL

VIOSER’s Quality Control Department having at its disposal the suitable Control laboratories and sufficient resources ensures that all the quality control activities, including product stability monitoring, are efficiently and reliably performed. The Qualified Person of VIOSER certifies each finished product batch, before release to the market and ensures that all the manufacture and control stages have been conducted in accordance with the Marketing Authorization, GMP and National Laws.

Logistics

Logistics

Logistics mainly consists of the process of planning, implementing and controlling the efficiency of cost flow, the storage of raw materials and products, the in process inventory and all related information from origin point, to the point of consumption. The ultimate goal of our Company is to guarantee impeccable customer services.

Our provided services include:

  • Written statement of customers service policy
  • Organization structure
  • System flexibility
  • Stock out level
  • Order information
  • Element of the order cycle
  • Expedite shipments
  • System accuracy
  • Product substitution
  • Product Tracing
  • Customer claims, complaints and returns
  • Product Replacement

Certifications: DY8/1348/2004, EN ISO 13485, EN ISO 9001