Centraleuropean Biotech Institute s.r.o. has a secured system of drug quality, which is built to meet the legal requirements set out in Act No. 362/2011 coll. on Medicines and Medical Devices, in the Decree of the Ministry of Health of the Slovak Republic No. 128/2012 on requirements for good manufacturing and good wholesale distribution practice, in the guidelines of the European Commission on good distribution practice of human medicines of November 2013 and other regulations. In the field of research and development, the company follows the European guidelines for good laboratory practice and good manufacturing practice, as well as European pharmacopoeias. The company Centraleuropean Biotech Institute s.r.o. holds the ISO 9001 certificate.

Quality policy

Centraleuropean Biotech Institute s.r.o. is committed to meeting customer requirements and increasing customer satisfaction by delivering products that meet or exceed applicable quality standards through continuous improvement of its products, services and QMS.

The management team will:

• Implement and maintain a formal QMS that complies with ISO 9001: 2015
• Ensure that QMS requirements are always met
• Review this policy at least every two years to ensure that the objectives are proportionate and effective
• Ensure that all employees and contractors are familiar with and clearly understand this policy

The Managing Director will ensure that the quality policy:

• is appropriate to the purpose of Centraleuropean Biotech Institute s.r.o.
• commits the organization to meeting these quality requirements and to continual improvement
• has a suitable framework to establish and review quality objectives
• is communicated to, and understood by, appropriate parts of the company
• is reviewed for continued suitability.

Quality objectives

Quality objectives are established during management reviews of the QMS. Management reviews can also initiate and monitor projects for achieving quality objectives.

The quality objectives of Centraleuropean Biotech Institute s.r.o. are to:

• implement the quality policy
• meet requirements for products and processes
• improve the QMS and quality performance

Quality management system planning

Quality system processes are planned to ensure that the system is appropriate for its intended purpose, and that it is effective and efficient. The purpose of the quality system is to:

• comply with the quality policy
• ensure and demonstrate the company’s ability to provide products that consistently meet customer and applicable regulatory requirements
• ensure a high level of customer satisfaction
• facilitate continual improvement
• comply with the requirements of the ISO 9001:2015 standard and applicable regulatory requirements as listed in Section 2 of this manual.