Reliability and Quality

Quality assurance plays a central role in pharmaceutical manufacturing. With our GMP-compliant quality management system, we guarantee satisfaction of the binding requirements established by healthcare officials for market approval. GMP (Good Manufacturing Practice) refers to the guidelines on quality assurance and production processes/environment in the manufacture of pharmaceuticals. The GMP standards establish guidelines for all relevant processes concerning quality assurance – from the receipt of goods to manufacturing and distribution. Implementation of these standards ensures our quality management system, which stipulates all processes.

Key areas of GMP standards

  • Documented use of drugs approved in Germany
  • Securing seamless traceability of all source materials used
  • Maximum requirements for on-site technical equipment
  • Microbiological environment monitoring in all manufacturing areas
  • Strict staff hygiene
  • Production processes defined in detail
  • Specially trained and qualified staff
  • Continuous education of employees
  • Establish separation of responsibilities in the independent work areas of manufacturing, quality control, and approval for the drug market
  • Self-inspections
  • Routine official audits