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
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
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 Assurance
QUALITY MANAGEMENT SYSTEM (QMS)
VIOSER’s Quality Management System ensures full compliance with the requirements of: ISO 9001:2015, EN ISO 13485:2016, 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 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.
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.
Environmental Policy
ENERGY POLICY
VIOSER S.A. is committed to the efficient use of energy in its industrial facilities related to parenteral solution production in order to conserve natural resources, reduce greenhouse gas emissions and contribute to mitigating the effects of climate change.
The Management of the company:
- Guides and promotes energy efficiency programs by ensuring that the whole organization operates in accordance with the principles set out in this policy
- Implements an Environmental Management System based on a continuous improvement process
- Ensures that our organization complies with applicable legislative and other requirements related to energy performance, use and energy consumption and which it co-signs.
- Sets targets for the continuous improvement of our energy performance and the reduction of greenhouse gas emissions. To achieve these goals, Management ensures the availability of the necessary information and resources.
- Supports the purchase of energy efficient products and services across our range of activities
- Encourages the adaptation of best practices, technical and technological innovations related to the use of energy in our production process and facilities.
- In order to achieve the awareness of all stakeholders, our company will provide reliable and transparent information on energy consumption, greenhouse gas emissions and improvement actions undertaken.
We believe that ensuring compliance with this policy is the responsibility of all individuals involved in our company's activities.
ENVIRONMENTAL POLICY
VIOSER SA is specialized in the production of parenteral solutions and holds a dominant position in the Greek market.
VIOSER SA recognizes the importance of preserving the environment as an integral part of a company's well-behaved and socially responsible behavior and is committed to implementing an Environmental Management System in line with the principles of ISO 14001: 2015 throughout its scope, aiming to minimize the impact of activities in the environment.
The company's Management has identified the threats and opportunities associated with its proper, efficient and environmentally friendly operation and is committed to:
- Protecting the environment and preventing pollution
- The production and marketing of environmentally friendly products built and operated in accordance with the principles of eco-design
- Comply with the provisions of existing Greek and European legislation
- Keeping it up to date on developments and amendments to environmental legislation
- Recognizing environmental aspects arising from the exercise of its activities by identifying those that may have significant environmental impacts and taking all necessary measures to prevent and prevent the environmental impacts that may be caused by its environmental aspects
- Implement a waste Management System in cooperation with licensed operators
- Defining environmental objectives and implementing programs to achieve them
- The rational use of natural and energy resources and the use of equipment and means of new, environmentally friendly technology where feasible
- Monitoring the parameters of its operation that may affect the environment in order to ensure compliance with the allowed emission limits of the existing legislation
- To support the participation and continuous environmental education of all employees who implement the environmental Management System in their daily lives
The company’s goal is to constantly improve environmental performance and reduce the environmental footprint of our business.
In order to achieve the above objectives, Management provides the necessary resources for the smooth, efficient and efficient operation of the company and the System.
The Environmental Management System is reviewed at regular intervals for completeness and effectiveness, and any modifications are communicated to the staff of the company.
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
