Quality

Ensuring high quality of products and services and the continual improvement of key processes is a major Krka strategy. Krka’s systematic approach is intended to ensure it exceeds customer requirements and achieves its operating objectives.

Integrated management system (IMS)

Since its beginning, Krka's strategy has been to manufacture high-quality, safe and effective medicines. Krka uses innovative approaches to manufacturing and follows good practices improved and perfected through development of the industry. In 1974, Krka was audited by FDA (Food and Drug Administration) for the first time and passed successfully. Krka has kept upgrading its good manufacturing practice (GMP) and other good practices (GXP) to improve further its quality management system, which has eventually evolved into the integrated management system (IMS). ISO 9001, Responsible Care (RC), ISO 14001, HACCP, BS OHSAS 18001, ISO/IEC 27001, ISO 22301 and Medical Device Directive (MDD) have been gradually included in the system. Excellent performance of IMS has been made possible by the continuously improving centralised system of document management introduced by Krka in 1993. Credibility of each system and IMS as a whole is confirmed by certificates issued by an external independent institution. Thanks to this approach Krka has been gaining the partners’ extended trust.

Our commitment to standards, guidelines and the PDCA (Plan-Do-Check-Act) approach result in constant improvements. They are the driving force of progress and permanent improvements in all areas of the Company's operations. The process management system covers every step from customer requirements via marketing, research and development, product supply and sales to the monitoring of customer satisfaction.

Quality system

The GMP (good management practice) system was Krka's first quality system, and the basis for the development of all other management systems. It has the effect of a legal requirement, so compliance with its requirements on pharmaceutical production and sales is essential.

The functioning of the quality assurance system is verified internally and externally. This means we also carry out the periodic verification of the quality systems of our suppliers and partners. Internal supervision over the quality management system is verified via internal audits performed by an experienced team of internal auditors.

The Krka quality system’s compliance with the standards is also reviewed and confirmed by external bodies (domestic and foreign state regulatory bodies, and assessed by certification organisations and Krka partners).

The function of all major quality processes are also periodically reviewed by the Quality Committee and the company management board, which together propose strategic guidelines for the implementation of Krka's development strategy.

Quality policy

Krka's Management Board has adopted the quality policy in compliance with strategic objectives. All Krka employees have been informed about the policy and it is also available to all interest groups. It is regularly reviewed and updated during reviews.

The quality policy involves the commitment to:

  • Improving and continuously upgrading the quality management system;
  • Monitoring quality of processes, products and services, setting measurable periodic targets aimed at constant improvement;
  • Improving products and services in accordance with the expectations and requirements of the clients and in compliance with the legal requirements that apply to the pharmaceutical production;
  • Providing for resources that will enable implementation of this policy;
  • Raising awareness and informing employees, suppliers, partners and clients (with regard to the requirements of individual interest groups) about changes and new developments in quality system management, and about products and services;
  • Engaging employees in training programmes and upgrading knowledge by motivating them for good work performance;
  • Providing for occupational health and safety, and healthy working environment;
  • Implementing Krka's quality policy in subsidiaries and representative offices in compliance with the Krka Group’s Quality Policy.

Business excellence

One of Krka's key objectives is to reach excellence in all its fields of operations, so IMS has been upgraded according to the EFQM excellence model, which was prepared by European Foundation for Quality Management.

Certificates (English)