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The Operational Excellence Academy
Self learn - Fundamentals of IQ OQ PQ Process Validation
When you understand IQ/OQ/PQ deeply, you can:
- Plan validation efficiently (reduce rework and delays)
- Execute protocols with confidence
- Write strong validation documentation (IQ/OQ/PQ protocols and reports)
- Reduce FDA inspection risk (fewer 483 observations)
- Build a validation approach aligned with ISO 13485 and FD
The IQ OQ PQ Framework (Qualification Stages)
1) Installation Qualification (IQ)
1) Installation Qualification (IQ)
1) Installation Qualification (IQ)
Installation Qualification (IQ) verifies and documents that equipment, utilities, software (if applicable), and supporting systems are installed correctly according to approved specifications and manufacturer requirements.
Key IQ concepts
- Installation verification
- Equipment qualification
- Utilities verification (compressed air, power, HVAC,
Installation Qualification (IQ) verifies and documents that equipment, utilities, software (if applicable), and supporting systems are installed correctly according to approved specifications and manufacturer requirements.
Key IQ concepts
- Installation verification
- Equipment qualification
- Utilities verification (compressed air, power, HVAC, cleanroom)
- Calibration status
- Software version / configuration
- Preventive maintenance requirements
- Materials of construction
- Traceability to URS / specifications
- Documented evidence (protocols, test results, deviations, approvals)
Why IQ matters: If equipment is installed incorrectly, everything downstream (OQ and PQ) is built on a weak foundation.
2) Operational Qualification (OQ)
1) Installation Qualification (IQ)
1) Installation Qualification (IQ)
Operational Qualification (OQ) verifies and documents that the process and equipment operate as intended across defined operating ranges. OQ typically includes testing of critical process parameters, alarms, interlocks, and controls—often including worst-case or boundary conditions.
Key OQ concepts
- Process parameter ranges
- Critical process
Operational Qualification (OQ) verifies and documents that the process and equipment operate as intended across defined operating ranges. OQ typically includes testing of critical process parameters, alarms, interlocks, and controls—often including worst-case or boundary conditions.
Key OQ concepts
- Process parameter ranges
- Critical process parameters (CPPs)
- Worst-case testing
- Challenge testing
- Alarms and interlocks
- Control limits / operating windows
- Process capability preparation
- Sampling plans
- Acceptance criteria
- Data integrity and traceability
- Statistical rationale
Why OQ matters: OQ builds confidence that the process can be controlled and will perform reliably before you run “real production” PQ lots.
3) Performance Qualification (PQ)
1) Installation Qualification (IQ)
3) Performance Qualification (PQ)
Performance Qualification (PQ) demonstrates that the process, when run by trained operators under normal production conditions using approved materials and procedures, can consistently produce product that meets all requirements. PQ is often executed using production-scale runs and focuses heavily on CTQs, product testing, and process co
Performance Qualification (PQ) demonstrates that the process, when run by trained operators under normal production conditions using approved materials and procedures, can consistently produce product that meets all requirements. PQ is often executed using production-scale runs and focuses heavily on CTQs, product testing, and process consistency.
Key PQ concepts
- Normal operating conditions
- Production equivalent runs
- Trained operators
- Released work instructions / SOPs
- Critical to Quality (CTQ) characteristics
- In-process and final inspection/testing
- Process capability (Cp, Cpk, Pp, Ppk)
- Lot-to-lot consistency
- Validation summary report (VSR)
Why PQ matters: PQ is the proof point that the process is truly ready for routine production and can repeatedly meet specs in the real world.
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How Quality Inspections and Statistics Support IQ OQ PQ
A strong IQ/OQ/PQ program uses measurement and data tools to make validation defensible:
- MSA (Measurement System Analysis) and Gage R&R ensure your measurement data is reliable
- (First Article Inspection) confirms initial conformance after setup
- CTQs define what matters most to safety/performance and compliance