Quality management

Quality management concerns the implementation, maintenance and monitoring of the quality management system in line with current medicines legislation in Slovenia, EU Member States and all other countries where Krka markets its products. The same level of quality is maintained across all Krka markets and demanded of key contractual partners as well.

We select the materials and APIs prudently, assess and control them in line with prescribed and approved procedures, and release them for further processing in production.

We monitor our in-house production of strategically important APIs, as well as the production sites of key contractual partners and suppliers of incoming materials. This assures the APIs are of suitable quality and comply with pharmaceutical industry regulations.

We assure data integrity, verify critical process phases, and employ manual and automated processes to prevent cross-contamination and mixing. We set down the requirements and monitor the technology-technical, laboratory and computer processes.

CONTINUOUS QUALITY ASSURANCE TRAINING

The large number of products and the requirements imposed by various markets mean we must provide continuous training to our staff and enhance the quality assurance of solid pharmaceutical forms, liquid and semi-solid non-sterile pharmaceutical forms and sterile pharmaceutical forms.

We control the production of finished products and assess the quality of each product batch before we release the product to the market. Quality is monitored throughout a product’s entire life cycle. We monitor data on medicinal product safety, process customer feedback on the quality of our products, conduct stability studies over the entire shelf life and prepare annual reports on the quality of our products, as well as introduce enhancements if needed.

QUALITY CONTROL WITH STATE-OF-THE-ART EQUIPMENT

The Quality Control department analyses materials and the packaging of APIs, bulk products and finished products. We use various techniques: physical-chemical techniques, liquid, gas and thin-layer chromatography, solid dosage form dissolution, structure control, spectometry and microbiological testing.

We use state-of-the-art equipment to carry out control-analytical testing before products are released to the market. This process allows us to ensure that our products are up to the required quality. Using timely analytical testing in tandem with other activities we evaluate product compliance, allowing for an uninterrupted supply of Krka products to the market.

Learn about quality management directly from Krka employees