Services

  • Thermal process validation: autoclaves, sterilizers, stability chambers, refrigerators, freezers and so on.
  • Cleanrooms, LAF cabinets qualification
  • HEPA filter testing according ISO 14644
  • Warehouse temperature and humidity monitoring
  • Computer Systems Validation according to GAMP5
  • Risk analysis (FMEA method)
  • Internal audits in accordance with GMP quality system requirements
  • Other GMP services: preparation of SOPs, VMPs, validation and others GMP documents
  • Laboratory equipment validation
  • Consultancy in cleanroom design according to GMP and ISO 14644 requirements
  • Training in GMP field