Validation & gmp services


Our offer of validation services performed by our team of specialists.

Range of application: isolators, glove boxes, pass boxes, hoods, ovens, filters, dispensing systems, HVAC / cleanroom system.

Documents Drafting & development
  • User Requirements Specification (URS)
  • Validation Master Plan & Project Plan (VMP/VPP)
  • Specification Documentation (FS)
  • Standard Operating Procedures (SOP)
  • FAT / SAT Protocols
  • IQ / OQ / PQ Protocols
  • P&Id
  • Requalification, Calibration, and Maintenance Protocols
  • Summary Reports
  • Design of production/areas according to GMP
Validation process
  • Thermal mapping of production areas
  • Risk assessment
  • Execution of FAT, SAT, IQ, OQ, PQ protocols.
  • Gap analysis

Instruments rental

Rental of calibrated instruments for validations and compliance tests
  • Aerosol photometer
  • Particle counter
  • Multifunction (Air velocity, Temperature, Humidity)
  • Thermometer
  • Manometer 1-10 bar
  • Micromanometer
For any information: