Quality Assurance

Avemar is manufactured by Biropharma Ltd. at Kunfehértó, Hungary under strict quality assurance systems. The quality and safety are assured by the employment of a HACCP system, the ISO 9001:2000 certificate and the GMP certificate for the production of pharmaceutical products issued by the National Institute of Pharmacy and supervised by the Ministry of Health, Hungary.

The manufacturing plant specializes in the production of extracts of plant origin. Besides producing Avemar, its own product, the plant provides contract manufacturing services to other pharmaceutical companies. Consequently, the plant respects pharmaceutical manufacturing quality assurance standards as a routine.

The biologically active ingredient of Avemar is called Avemar Pulvis. The fact that Avemar Pulvis is not one single type of molecule, but a complex arrangement of different molecules, does not hinder the strict quality assurance that is ensured during the course of the manufacturing.

The production of Avemar is protected by an international patent. The description of the patent includes quantitative and qualitative parameters that shall be observed in order to assure that the production based on the extraction. Although the quality assurance of Avemar is a complex system, it’s worth mentioning that one of the significant elements of the quality assurance of Avemar is the HPLC (High pressure liquid chromatography) fingerprint analysis. The HPLC fingerprint is a type of analytical fingerprint used by analytical chemistry. The primary goal of this analytical method is not identifying the ingredient molecules of this complex arangement of different molecules, but rather its description of the concentration of the different molecules found in the analyte by a mathematical curve (called chromatogram). During the course of the manufacturing process of Avemar, the HPLC fingerprint chromatograms are regularly prepared and then compared to the reference chromatogram in order to verify if the composition (and therefore the effectiveness) of the end product of each production shows equivalency to that of the complex of molecules specified in the patent.