Commissioning, Qualification & Validation (CQV)
We provides comprehensive Commissioning, Qualification & Validation (CQV) services to ensure pharmaceutical facilities, utilities, equipment, and manufacturing systems are designed, installed, operated, and perform in accordance with user requirements, regulatory expectations, and GMP standards.
Our experienced validation professionals deliver scientifically sound, risk-based, and fully documented CQV solutions that support regulatory compliance, operational reliability, and product quality throughout the facility lifecycle.
Standard We Follow:
- EU GMP Annex 15
- EU GMP Annex 1
- FDA Guidance
- WHO GMP
- PIC/S GMP
- ISPE Baseline Guides
- ASTM E2500
- GAMP® 5 (where applicable)
- ICH Q9 (Quality Risk Management)
- 21 CFR Part 11 (for computerized systems)
Facilities
- 1. Cleanrooms
- 2. Laboratories
- 3. Warehouses
- 4. Controlled Storage Areas
Utilities
- 1. Purified Water (PW)
- 2. Water for Injection (WFI)
- 3. Pure Steam Systems
- 4. Compressed Air & Process Gases
- 5. Nitrogen Systems
- 6. Vacuum Systems
- 7. Chilled Water Systems
- 8. Boiler Systems
Process Equipment
- 1. Reactors
- 2. Mixing Vessels
- 3. Manufacturing Tanks
- 4. CIP Systems
- 5. SIP Systems
- 6. Autoclaves
- 7. Dry Heat Sterilizers
- 8. Depyrogenation Tunnels
- 9. Ovens
- 10. Fluid Bed Dryers
- 11. Granulators
- 12. Tablet Compression Machines
- 13. Coating Machines
- 14. Filling Machines
Laboratory Equipment
- 1. HPLC
- 2. GC
- 3. UV-Visible Spectrophotometers
- 4. FTIR
- 5. TOC Analyzers
- 6. Stability Chambers
- 7. Refrigerators & Freezers
Why Choose Cleanstep?
Process Equipment
- 1. Complete CQV Lifecycle Support
- 2. Experienced CQV Professionals
- 3. Regulatory-Compliant & Audit-Ready Documentation
- 4. Technology-Driven & Efficient Execution
- 5. Comprehensive Facility & Utility Qualification
- 6. Trusted Technical Partner
Key Deliverables
Each CQV project includes:
- 1. Commissioning Plan
- 2. Validation Plan
- 3. Risk Assessment
- 4. Design Review
- 5. DQ Report
- 6. FAT/SAT Review
- 7. IQ Protocol & Report
- 8. OQ Protocol & Report
- 9. PQ Protocol & Report
- 10. Calibration Certificates
- 11. Raw Data
- 12. Deviations & CAPA Records
- 13. Traceability Matrix (where applicable)
- 14. Final Summary Report
Need Commissioning, Qualification & Validation (CQV) Services?
Partner with Cleanstep Pharma and Engineering Solutions for reliable, risk-based, and regulatory-compliant CQV solutions. We ensure your facilities, utilities, and equipment meet GMP requirements through comprehensive qualification, audit-ready documentation, and efficient project execution.
