Our quality assurance system

In accordance with the current requirements stipulated by the Medicines Law (ยง 64,67,72a AMG) and the Medical Agent Directive (AMWHV) which are based on the EU Guideline governing Good Manufacturing Practices for Medicinal Products for Human and Veterinary Use (GMP Guideline Part II), we have introduced a quality assurance system which covers all of our work processes. Our quality assurance system includes the formation of a quality assurance unit and a manual outlining detailed procedural instructions. Monitoring is performed by the responsible health authorities in Hamburg.

On request, we enable our customers to perform audits on our premises.