Qualification
IQ, OQ, and PQ qualification for pharmaceutical storage equipment and environments. Structured, documented, and designed to hold up under regulatory inspection.
What Is Equipment Qualification?
Equipment qualification is the process of demonstrating that pharmaceutical storage equipment is correctly installed, operates as intended, and consistently performs within the specifications required for product safety and compliance.
Unlike one-off testing, qualification is a structured, lifecycle approach — covering installation, operational performance, and real-world performance under routine conditions. Each stage produces documented evidence that forms part of the organisation's ongoing regulatory compliance record.
The Three Qualification Stages
Installation Qualification
Verification that equipment has been delivered, installed, and configured in accordance with manufacturer specifications and design requirements.
- Equipment identity and specification verification
- Installation location assessment
- Utilities and supply connections check
- Calibration status confirmation
- Documentation and drawing review
Operational Qualification
Verification that equipment operates within defined limits across its full operational range under controlled test conditions.
- Temperature range performance testing
- Control system and alarm functionality testing
- Door open / recovery time testing
- Power interruption / recovery testing
- Calibration and sensor accuracy verification
Performance Qualification
Verification that equipment consistently performs within specifications under simulated or actual routine operating conditions.
- Extended performance study under load
- Seasonal performance assessment
- Worst-case condition testing
- Statistical data analysis and reporting
- Acceptance criteria review and sign-off
Equipment & Environments We Qualify
Standards Referenced
What We Deliver
Ready to qualify your equipment?
Tell us about your equipment and we will scope the right qualification approach.