Product quality and patient safety

Product quality and patient safety

Our products and services are known for high-quality standards in all parts of the world. Positive responses from patients, physicians, pharmacists and regulatory bodies are something we value the most.

Quality, safety and efficacy of products and APIs

We examine the quality of our products with many laboratory tests under state-of-the-art analytical methods, devices and procedures.

Integrated quality management system

The effective performance of our quality system in compliance with the principles of good pharmaceutical practices (GxP) and regulations governing quality in the pharmaceutical industry allows us to continually improve our products, processes and services.

Fair disclosure of adverse effects, product labelling, and anti-counterfeiting

We have the pharmacovigilance system in place to monitor an individual medicinal product throughout its shelf life. Each product batch is traceable, which ensures an audit trail from the start of production until the product’s expiry date.

Animal welfare

By carefully planning the selection and development of new veterinary products and adhering to guidelines in animal healthcare, we contribute to improving the animals welfare.

Goals

Ensure development in compliance with the strictest quality, safety and efficacy standards and satisfy uniform requirements for products in all Krka’s markets.
Upgrade the development and production of APIs and products based on constant monitoring and assessment of production; actively participate in continued promotion of professional, technological, infrastructural, and personnel know-how in development and production, and hence fully implement the vertically integrated business model, which gives us the competitive edge and ensures reliable supplies of APIs and products.
Raise awareness among employees about (i) the culture of quality in the Krka Group; (ii) the importance of quality and correct regular work in ensuring quality, safe and efficacious products; and (iii) the importance of every person for attainment of our goals.

OBJECTIVES BY 2028

Critical non-compliances established in inspections by authorised bodies or partner audits: 0

Complaints to released batches ratio: < 1%

Krka around the world