GxP Standards and More

Highest hygiene standards, managing contamination, and securing production chains – we know what’s important!

Hygiene
  • Comprehensive adherence to GxP standards for developing and implementing hygiene concepts to ensure drug safety
  • ALCOA+ concepts for data sets and documentation (traceability, quality)
  • Compliance with relevant DIN/ISO standards for documentation and processes
  • Deployment of qualified personnel to monitor and ensure process steps
Production
  • Cleanroom technology: ensuring hygienic standards and preventing contamination
  • Validation and qualification of all production facilities and processes according to GMP guidelines
  • Use of cutting-edge cleanroom technology and procedures such as pressure differential control, personnel airlocks, and gowning requirements
Secondary Processes
  • Cleaning and hygiene services for pharmaceutical standards
  • Waste disposal to ensure smooth operations
  • Security services to ensure the surrounding environment meets the highest standards
Quality
  • Assistance in meeting GxP, DIN EN ISO 9001, and DIN EN ISO 13485 requirements
  • Comprehensive internal quality management and regular training for staff
  • Conducting quality controls and audits to ensure product quality
  • Continuous quality monitoring and regular internal audits

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