Quality Control
The Quality Control laboratory is a holder of the Certificate of compliance with the requirements for good manufacturing practice issued by the State Institute for Drug Control with identification number 521.
The Quality Control department includes:
- Instrumental analysis laboratory
- Physical–chemical laboratory
- Microbiological laboratory
In addition to the initial, final and inter-operation analyses of raw materials, packages and final products, we provide microbiological monitoring of the production areas, equipment, media and employees. Beside the stability studies of drugs, we also test stability of dietary supplements and hard gelatin capsules.
We perform the analysis according to the requirements of the Czech Pharmacopoeia or internal regulations, which are regularly validated. We respond flexibly to the changes of the legislative requirements. In terms of the analytic procedures, we are able to meet the individual requirements of our customers. Regular training of the Quality Control staff with emphasis on the improvement of their skills and qualifications is commonplace in our company.
Our laboratories are equipped with instruments that meet high qualification requirements. For example, we work with Agilent high performance liquid chromatograph (HPLC), Unicam UV-spectrophotometer, Binder stable chamber, Sotax dissolution testing equipment, Bűchi melting point apparatus, Labox microbiological safety cabinet, Hewlett-Packard gas chromatograph (GC), etc. The equipment is subject to periodical service maintenance, validation and, where applicable, calibration, and is renewed and added on a regular basis.
Dear customer, quality and efficiency of a product are always our top priority. We use the principles of GMP to produce and check not only medicines but also food supplements.
Quality of products is our primary goal.