Validation
Execution of GMP activities:
- URS
- VALIDATION PLAN
- RISK ASSESMENT
- TRACEABILITY MATRIX
- FS, SDS, HDS
- FAT, SAT
- DQ, IQ, OQ, PQ
- VALIDATION REPORT
Equipment Validation
Equipment Validation includes:
- COMMISSIONING & QUALIFICATION of utilities, equipment and facilities
- THERMAL MAPPING: instruments, autoclave, sterilizing tunnels, freeze dryers
- VALIDATION PROCESS of STERILIZATION AND LYOPHILIZATION
- VALIDATION OF PACKAGING MACHINES
- LEAK TEST FOR ABSOLUTE FILTERS
- AIR FLOW SMOKE PATTERN TESTING
- CLASSIFICATION OF AREAS AND PARTICLES MONITORING (std ISO/GMP)
- SOP statement: maintenance and sampling
- INSTRUMENT CALIBRATION PLAN
CSV
In addition to the validation activities mentioned above, the COMPUTER SYSTEM VALIDATION deals specifically with:
- Issuing procedures in order to maintain the validate state of systems: ACCESS MANAGEMENT, CONFIGURATION CHECK, PERIODIC REVIEW, BACK UP & RESTORE, DISASTER & RECOVERY
- PERIODIC REVIEW
- DATA INTEGRITY ASSESSMENT
Calibration
Calibration of electronic and penumatic instruments for industrial plants following LAT/EA certified standards and according to the latest technologies.
Calibration of industrial instruments for:
- Weight
- pH
- Conductivity
- Rotation speed
- Flow
- Pressure
- Temperature
- Humidity
- Smoke and gas detection sensors, fire protection system
- Electrical and pneumatic quantities
