GMP-compliant production

Quality assurance plays a central role in the manufacture of pharmaceutical products. Our GMP-compliant quality management system enables us to satisfy the statutory requirements for market release as defined by the health authorities.

GMP (Good Manufacturing Practice) incorporates the guidelines for the quality assurance of the production processes and environment used in the manufacture of medicinal products. The GMP guidelines lay down standards which govern all quality assurance processes, from the receipt of incoming goods to production and, finally, distribution. Our quality management system, which precisely defines each and every process, ensures that these standards are implemented.

The key points are:

• verifiable use of medicinal products approved for use in Germany
• to guarantee the complete traceability of all starting materials used
• facilities must meet with the most stringent of requirements regarding technical equipment
• microbiological environmental monitoring in all manufacturing areas
• strict personal hygiene for staff
• detailed specification of production processes
• specially trained and qualified personnel
• continuous further training for staff
• clear division of responsibilities between the separate areas of manufacture, quality control and release for the medicinal products market
• self inspections
• regular inspections carried out by the relevant authorities