Quality Assurance

COOPER SA follows written procedures drawn up in accordance with international standards and GMP guidelines, as well as the ISO 9001:2015, ISO 13485:2016, standard and supervises all production processes as well as the reliability of installations, equipment, systems and all testing and production proceedures.

It also applies the principles and guidelines governing correct practice for storage and distribution of Medical Products and Devices, in accordance with Ministerial Decision DY8/1348/2004, and holds the relevant certificate from the competent certification agency, the Research Center for Biomaterials (EKΑPTY SA).

COOPER SA collects and monitors the safety data for all medicinal products marketed, in accordance with the guidelines governing Pharmacovigilance internationally.

For any report of an adverse event/reaction or a quality complaint about a COOPER SA product you can call at +30 2103462108  or send an email to the following address:
pharmacovigilance@koper.gr

For the needs of pharmacovigilance, the company collects personal data, based on the current legislation related to the safety of medicines. Data is stored for a period defined in the current legislation. Sending information or personal data to the above-mentioned email address, indicates your consent about data processing.

For FRESENIUS KABI products you can call at +30 210 6542 909 or send an email to the following address: FKHinfo@fresenius-kabi.com

Our objective in Cooper Pharmaceuticals is to ensure that every product, meets customers and regulatory expectations for quality, safety and efficacy. Our commitment is to create an advanced Quality System applicable across the life cycle of each product through a continuous, in-depth and forward-looking monitoring of the pharmaceutical and medical devices regulatory environment.

Quality is fully integrated into our global business processes, it is seen as a joint responsibility of all personnel and it is achieved by combining the collective ambition and individual contribution at all levels of Cooper Pharmaceuticals.

The quality of our products is assured by the cumulative effect of the premises, equipment, materials, services and personnel involved directly and indirectly in the processes.

Our main target is to produce high quality products that meet our customer’s expectations. Therefore, we :

• Ensure patient safety through risk management, quality assurance of products and compliance with at least ISO 13485:2016, ISO 9001:2015, ISO 37001:2016, ISO 14001:2015, GMP and Medical Device Regulation (MDR) 2017/745 (where applicable)
• Comply with all relevant applicable legal and regulatory requirements
• Seek for the continuously enhancement of customers’ satisfaction
• Track and apply new innovative technologies.
• Maintain and continuously improve the effectiveness of our Quality Management System in every aspect of business processes
• Invest in the continuous improvement of our personnel through continuous training.

Cooper has implemented a Quality Management System to serve the above objectives and is engaged to provide the necessary resources to support it.

For Cooper Pharmaceuticals,

Date: 21/05/2024

NIKOLAOS MELAS
CEO

Download pdf file here

COOPER Pharmaceuticals s.a.  acknowledges our responsibility to be an active part of protecting the environment, fighting climate change and preserving natural resources. This is why we implement a clear, well-round environmental policy to reduce our ecological footprint.

COOPER Pharmaceuticals s.a., records, analyses and implements environmental programs aimed at reducing our impact on the environment (ecological footprint). This environmental policy is an integral element of the Company’s corporate and product strategy.

COOPER’S Central/Top Management is committed to continuously improving the Company’s environmental footprint through:

• the identification of the environmental aspects & impacts of the Company per process / activity as well as the evaluation of their criticality,
• the recording and analysis of the environmental data related to the Company’s performance, specifically:
• Consumption of natural resources
• Recycling of materials (e.g. electrical/electronic equipment, batteries
• Management of solid and liquid waste
• Management of hazardous waste (e.g. batteries, unusable products)
• CO₂ emissions into the atmosphere through transportation processes
• Implementation of environmental programs to reduce impacts that are assessed as critical
• Defining measurable objectives and corresponding indicators (KPIs) for the environmental management
• Identification and evaluation of potential risks and opportunities related to environment, per process/activity and the adoption of prevention and countermeasures
• Maintaining a high level of environmental awareness among the personnel through continuous training and information
• Periodic evaluation of all Company’s suppliers, partners and sub-contractors with qualitative and environmental criteria
• Implementation of emergency response plans to ensure the protection of the health and safety of staff and third parties as well as the protection of the environment
• Implementation of Management system according to 14001:2015 ISO International Standard.
• Operating with environmentally friendly practices, based on legal and regulatory requirements related to climate change.

For this purpose, COOPER Pharmaceuticals s.a., continuously and systematically checks/monitors the applicable legal instructions and requirements, resulting from these related tasks which are then documented and included in the Company’s Management System.

The Company’s unified Management System is audited by an independent certification body, ensuring that Cooper’s commitment to environmental management can be compared to domestic and international benchmarks.

It is also the responsibility of the Company’s Management to ensure that the Quality Policy is communicated, understood and applicable by all of the Company’s personnel, with the ultimate goal of the continuous, stable development of its business activity with unwavering adherence to its principles and the continuous offering its customers products and services of the highest quality.

For Cooper Pharmaceuticals,

Date: 21/05/2024

NIKOLAOS MELAS

CEO

Download PDF file here