IQ, OQ, PQ: Equipment Validation
The three-stage qualification process ensuring laboratory equipment and systems meet specifications and perform reliably.
Understanding IQ, OQ, PQ
- Validation IQ/OQ/PQ
- IQ (Installation Qualification), OQ (Operational Qualification), and PQ (Performance Qualification) represent the three stages of equipment validation required by regulatory agencies. These protocols provide documented evidence that equipment is properly installed, operates correctly, and consistently produces expected results.
IQ - Installation Qualification
Verifies that equipment is delivered, installed, and configured according to manufacturer specifications and design documentation.
Key IQ Elements:
- Verification of equipment receipt and condition
- Confirmation of correct model, serial number, and components
- Environmental requirements verification (power, space, climate)
- Software installation and version confirmation
- Network connectivity and integration testing
- Documentation of all installation activities
OQ - Operational Qualification
Demonstrates that equipment operates as intended across all anticipated operating ranges and parameters.
Key OQ Elements:
- Functional testing of all features and capabilities
- Testing at operational limits (high/low ranges)
- Alarm and safety system verification
- User interface and workflow testing
- Integration with other systems verification
- Access control and security testing
PQ - Performance Qualification
Confirms that equipment consistently produces expected results under real-world operating conditions with actual samples and workflows.
Key PQ Elements:
- Testing with actual samples or representative materials
- Multiple test runs to demonstrate reproducibility
- Verification of accuracy and precision
- Complete workflow execution testing
- Operator competency verification
- Performance against predefined acceptance criteria
Validation Documentation
Validation Master Plan
Overall strategy and approach for validation activities
User Requirements Specification
Detailed functional and operational requirements
Validation Protocols
Step-by-step procedures for each qualification phase
Test Scripts
Specific tests with acceptance criteria and expected results
Deviation Reports
Documentation of any issues and their resolution
Validation Summary Report
Final report documenting validation completion
LIMS Validation
For Laboratory Information Management Systems, validation follows the same IQ/OQ/PQ framework but includes additional elements like data migration validation, interface testing, audit trail verification, and 21 CFR Part 11 compliance testing for electronic records and signatures.
Regulatory Requirements
IQ, OQ, PQ validation is required by multiple regulatory frameworks: