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The policy on quality, environment, occupational health and safety

We want to improve peoples’ lives, creating high-quality products. Responsibility  is a priority in any decision we take. Quality, value, dedication towards patients, respecting our obligations to our employees, shareholders, suppliers, distributors, community, are aspects on which Antibiotice focuses. Only this way the partners will prosper along with us.

With an experience of 60 years in the pharmaceutical industry in Romania, Antibiotice is a manufacturer of generic drugs, the single romanian manufacturer of solid parenteral products and unique manufacturer of active pharmaceutical ingredients obtained by biosynthesis. A quality management system oriented to the client is implemented and continuously improved in the company, complying with the requirements of the Good Manufacturing Practice rules and other applicable pharmaceutical industry guidelines. The system is certified according to the requirements of the international standard EN ISO 9001:2008.

In the aim of:
• continuously improving the performances by a strict control of the impact of all the activities within the company and
• offering the highest quality products in line with the requirements specified in the standards, specified/non-specified requirements of the customers, applicable legal and regulatory requirements, without affecting the safety and health of employees, environment and properties around the company,

we implemented an integrated management system for quality, environment, occupational health and safety, while complying with the requirements of EN ISO 9001:2008, EN ISO 14001:2004 and OHSAS 18001:2007.

Through the analysis conducted by the management, internal audit, through communication and staff training as well as by applying corrective and preventive actions, cooperation of the mixed teams involved in the analysis and problem solving, we commit ourselves to:
• continue and strengthen our business by manufacturing and supplying  competitive, high-quality, safe and effective products for continuously satisfying the demands of our customers
• continuously improve the effectiveness of the integrated management system in order to meet the customers’ requirements, prevent pollution, occupational injuries and diseases as well as reduce any risk regarding health and safety at work
• meet the applicable legal and regulatory requirements and other specific ones to which the company is aligned
• to continuously adapt the system,  communicate the company’s policy to our staff, suppliers and customers  and make sure that all have understood it.
• improve the company’s financial performance by reducing the costs related to quality issues (cost of repairs, reprocessing, complaints/recalls)
• regularly evaluate and comply with the policy and legal requirements, improve permanently our performance by conforming to relevant regulations relating to the product quality, environment, health and safety at work.

To ensure the operation of the integrated management system, we set objectives based on performance resulted not only from the technical expertise but primarily from the policy implementation. The objectives are monitored, measured and periodically evaluated by the top management. In addition, all the company’s employees are trained and made aware of the management system instruments and resources are provided to ensure the effectiveness of these methods.