Quality Assurance

quality assurance logo

Avemar™ Pulvis, the active ingredient in Avemar™, is the dried form of fermented wheat germ extract (FWGE). The special, patented production process include: the fermentation of wheat germ by Sacharomyces cervisiae, the extraction of the fermentation liquid, and spray drying. During the entire process only natural compounds are used.

Avemar™ products are manufactured by Biropharma Ltd. under strict quality assurance systems. The quality and safety are assured by the HACCP system, the ISO 9001:2008 certificate issued by SGS Yarsley International Certification Services, and the GMP certificate for the production of pharmaceutical products. The production plant is supervised by the Ministry of Health, Hungary and SGS Yarsley.

The production of Avemar™ is protected by an international patent. The description of the patent includes quantitative and qualitative parameters. The quality assurance of Avemar™ is a complex system, and one of its most significant elements is the HPLC (High pressure liquid chromatography) fingerprint analysis. During the manufacturing process  HPLC fingerprint chromatograms are regularly prepared and compared to the reference chromatogram. This step is important in order to verify, that the molecular composition corresponds with the patent. Due to the strict assurance system the composition of every batch is analysed and compared to the registered standard described in the patent.