As a manufacturing company focusing on medicinal products, medical devices and dietary supplements, we implemented an integrated Quality Assurance System.The system necessitates observing numerous strict requirements and maintaining the necessary standards of manufacturing which guarantee patient safety.Furthermore, Medicofarma S.A is under constant supervision of the Chief Sanitary Inspector overseeing health safety




ISO 13485

Medicofarma S.A. Certificates:

HACCP Certificate

As a company with a HACCP certification, we can guarantee complete safety of our products to the customers.The HACCP stands for Hazard Analysis and Critical Control Points. It includes standards, rules and procedures for safety management of food products. Medicofarma S.A passed an inspection by the national sanitary and epidemiological safety office (Sanepid) and was certified as compliant with the relevant HACCP safety protection standards.

GMP Certificate

We successfully developed and implemented the GMP – Good Manufacturing Practices standard. The principles of GMP include maintaining high quality and purity of raw materials and semi-finished products used to manufacture the finished product.Suppliers and materials used in the manufacturing processes are also subject to regular evaluation. By receiving the GMP certificate, we confirm that: our technological processes are valid and comply with the assumed parameters; we observe the standards for food safety; the health benefits and identification of our products are sound. The GMP system falls within scope of HACCP which ensures the safety of food products.

ISO 13485 Certificate

After evaluation, we were certified as compliant with the ISO 13485 standard for medical products. We also received an extended license to include carrying out microbiological examinations together with manufacturing and analytical examinations of medicinal products intended for clinical trials. The ISO 13485 standard applies to the quality management systems implemented for the group of medical products. ISO 13485 entails introducing necessary requirements during design, development, manufacturing and implementation of medical products. Medicofarma S.A received the ISO 13485 certificate at the beginning of 2020, confirming our devotion to the quality and safety of our products.

ALFA Certificate

Medicofarma S.A. received the ALFA certification which permits manufacturing supplementary fodder mixes for pets – service animals. The Chief Veterinary Inspectorate issued a permit allowing us to expand the range of manufactured products to include preparations for animals. Individual stages of manufacturing and storage were checked and approved by the above mentioned office. It was therefore confirmed that we meet the necessary requirements for this kind of production.