Galenika is a holder of a number of GMP certificates

Pharmaceutical Quality System has become an inevitable element in increasing competitiveness and survival of the organization in the global pharmaceuticals market, whereas the implementation of all quality standards is a requirement for the entire organization. According to the best practice, effective quality management system in Galenika is adopted through implementation of GMP guidelines and ISO standards.

For many years, Galenika has been achieving significant results in implementation of Good Manufacturing Practice requirements, a term globally recognized in production and quality control of pharmaceutical products. We have achieved the highest quality level in this field and demonstrated the achievement by acquiring EU GMP Certificate for the Solid Dosage Forms Plant in 2017. We also hold GMP Certificate issued by the Russian Federation for all the products registered in this country.

Today, Galenika holds GMP Certificates issued by the Serbian Ministry of Health for all its drug manufacturing plants. The GMP conformity of its Quality Control has also been demonstrated through audits performed by contracting partners.

Our product designing, manufacturing, installing, and servicing processes comply with user requirements and legal regulation, and result from ISO 9001 implementation and maintenance.

Implementation of HACCP system, based on the risk and preventive action analysis, has secured production of high-quality dietary supplements. In 2018, we successfully completed implementation of a new version of ISO 9001:2015 standard as well as recertification according to the new requirements issued by the German TÜV SÜD Management Service. This resulted in creating favourable conditions for improvement of our product quality, increase in user satisfaction, measurement of system performance, and further improvement of our company’s processes and overall image.

Our certificates

We have also completed re-certification according to HACCP standard for dietary supplements as well as change of Certification company.

Product quality and safety policy