Qualification & Validation
We provide Onsite / Offsite qualification services for the pharmaceutical facilities, cleanrooms, and equipment (manual /automated) & laboratory instruments. Our service includes:
- Equipment requalification
- Facility qualification
- HAVC qualification
- Qualification of critical utilities (Nitrogen Generator/Compressed Air)
- Water system qualification (Purified water/Pure steam/Water for injection)
- Protocol development, execution, and reports for Risk analysis, FDS, DQ, IO, OQ, and PQ
- Qualification project management
- Computer system validation
- Laboratory instrumentsPLC, SCADA, BMS ,EMS
- Cleaning validation
- SIP and CIP validation
- GAP analysis
- Document management
- Factory acceptance test / Site Acceptance
- Master planning (commissioning, qualification, and validation
- Risk-based approach for qualification lifecycle
- Re-establishment of Qualification of existing equipment (including design/drawing/ FDS/ DQ, IO, OQ)
- Existing Equipment / system upgradation from manual to automated (PLC / SCADA)
Validation services
- Process validation
- Hold time study
- Process Simulation Validation / Media Fill
- Area validation / HVAC Validation
- Stability programme design / execution / Stress stability study
- Transport validation
- Risk-based assessment of supply chain and validation
Method development and Validation for
- Assay
- RS
- Product Impurities
- Nitrosamine
- Elemental impurities
Method development and validation for microbial test method:
- Total microbial count
- Pathogen
- Sterility
- BET
- Microbial assay for product efficacy
- Disinfectant efficacy
- Preservative efficacy Test
