Pharmaceutical cold storage requires validated commissioning following DQ/IQ/OQ/PQ framework.
DQ — Design Qualification
Performed during pre-construction.
- Documentation that design meets user requirements
- Documentation that design meets regulatory standards (cGMP, GDP)
- Approval signatures from owner's validation team and regulatory affairs
IQ — Installation Qualification
Performed during construction installation.
- Verification that systems are installed per design specification
- Materials of construction verified
- Equipment serial numbers documented
- Calibration certificates collected for instruments
- IQ protocols executed and documented
- Approval signatures
OQ — Operational Qualification
Performed at substantial completion.
- Verification that systems operate within specified parameters across full operating range
- Test scripts executed and documented
- Edge cases tested (high temperature alarms, low temperature alarms, redundancy transitions)
- OQ protocols executed and documented
- Approval signatures
PQ — Performance Qualification
Performed before facility goes operational.
- Verification that systems perform consistently under actual operating conditions over time
- Sustained operation (typically 4–8 weeks) under monitored conditions
- Temperature mapping over the PQ window
- Documentation of any deviations
- PQ protocols executed and documented
- Approval signatures from owner's validation team and regulatory affairs
Validated commissioning typically adds 4–8 weeks to the commissioning timeline compared to non-validated commissioning.
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