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)

From the very start of operations, Krka's strategy has been to produce pharmaceuticals meeting every requirement of quality, efficacy and safety. We use the latest methods and good pharmaceutical production practice, which has been supplemented and improved over the years, in line with developments in the sector. As early as 1974 Krka successfully requested and passed an inspection by the US Food and Drug Administration. To ensure we keep one step ahead of the continually developing requirements of GMP (good manufacturing practice) and other GxP standards, Krka has improved its quality management system, which developed within its IMS. The following systems have been gradually incorporated into the Integrated Management System (the year next to the system indicates the year of certification): 1996 – ISO 9001, 2000 – Responsible Care (RC), 2001 – ISO 14001, 2004 – HACCP, 2005 – OHSAS 18001, and 2007 – ISO 27001. The excellent performance of the IMS is supported by the centralised document management system, which Krka set up in 1993, and which has also been continually improved. The credibility of each system and the IMS as a whole is confirmed by the certification acquired from independent external agencies. This approach ensures we can continually increase our partners trust in our systems and products.

The continual improvements dictated by the standards and guidelines and the PDCA approach (Plan, Do, Check, Act) on the one hand, and Krka’s commitment to such standards on the other, is the driving force behind the progress and continuous improvement in quality in every area of Krka 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.

Business excellence

One of Krka’s key objectives is to achieve excellence in every area of operation, which led to the IMS being upgraded to take into account the principles of the EFQM excellence model, which is produced by the European Foundation for Quality Management.