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
- Requalification, Calibration, and Maintenance Protocols
- Summary Reports
- Design of production/areas according to GMP
- Thermal mapping of production areas
- Risk assessment
- Execution of FAT, SAT, IQ, OQ, PQ protocols.
- Gap analysis
Rental of calibrated instruments for validations and compliance tests
- Aerosol photometer
- Particle counter
- Multifunction (Air velocity, Temperature, Humidity)
- Manometer 1-10 bar