Quality management system
SALUS Haus manufactures pharmaceuticals and is in possession of a manufacturing license according to § 13 German drug law and an import license according to § 72 German drug law, both issued by the competent authority of the Government of Upper Bavaria. The manufacturing license includes the production of herbal medicines, as well as the testing and release of non-sterile products. The production is carried out in accordance with the guidelines of the Good Manufacturing Practice (GMP). The compliance with these guidelines is regularly verified by our competent authority, the government of Upper Bavaria, in multi-day audits and confirmed with a GMP certificate.
The GMP guidelines describe in detail the requirements for the production, testing and release of medicinal products. This includes, among other things, the requirements for a trained personnel, suitable and qualified equipment, correct documentation, production and quality control, validated computer systems, validated processes and analytical methods. The fulfilment of these high standards guarantees the best possible quality and safety of the products.
The requirements of the Good Distribution Practice (GDP) guideline which describes a proper distribution, storage and transport of medicinal products are also met.
We have installed a uniform over-all quality management system in our house and therefore apply the described GMP standard also for non-pharmaceutical products. In addition, however, food-specific quality systems are also integrated, such as an established HACCP concept (Hazard Analysis and Critical control points) and an allergen management system.
We are also regularly inspected by the American Food and Drug Administration (FDA) for food supplements produced for the United States. In these audits, the compliance with 21 CFR Part 111 for dietary supplements is verified.