Krka has become synonymous with quality, as quality is the foundation on which we develop and manufacture our products. Quality is of strategic importance and something that gives us a competitive advantage.

Quality is embedded in every aspect of our products throughout their lifecycles

Products of the highest quality are a top priority for all Krka employees. We carefully monitor products throughout their lifecycles – from their development to their placement on the market, and the duration of their shelf lives.

Analyses are an essential part of quality assurance. We perform them in the most advanced laboratories. We check all raw materials and finished products, those manufactured at Krka and those supplied by our partners. We constantly optimise work processes and increase laboratory capacities to ensure we can supply our products to the markets on time.

Careful selection of raw materials

The quality system is applied as early as the inspection of raw materials used in producing finished products (APIs, excipients, packaging materials). We audit our suppliers and assess risks. We examine raw materials in control laboratories, and responsible persons assess their quality and approve their use in production.

Production under the microscope

Production of APIs and finished pharmaceutical products takes place according to the prescribed procedures, which are strictly adhered to. All our production facilities and equipment are adequately qualified, and our personnel is highly skilled. We closely monitor the manufacture of each product batch and review all relevant manufacturing and analytical documents. Based on this, we can confirm that our products are made in compliance with the prescribed procedures and good practice guidelines and satisfy the marketing authorisation requirements.

Assessment before placing a product on the market

All manufactured product batches are assessed in compliance with the standards of good manufacturing practice and registration requirements. They are assessed by qualified persons (QPs) for the release of individual batches to the market. Their assessment takes into account the laws of the countries where our products are marketed. When product quality is confirmed, the warehouse inventories are released, and the products are prepared for transport to wholesalers or customers.

From feedback to improvements

We track the feedback from our markets and the safety of our products in daily use and verify their quality throughout their shelf lives. Our patients always come first, from analysing their needs during the development of our products to monitoring their experience when they start using them. This is our way of maintaining their trust as we remain one of the leading generic manufacturers in the world. Taking care of product safety and quality never ends.