Installation Qualification in Pharma: What IQ Proves and How It’s Done
Definition
IQ full form is Installation Qualification. In pharmaceutical qualification and validation, Installation Qualification is the documented verification that equipment, utilities, or systems are installed correctly and match the approved design, specifications, drawings, and manufacturer recommendations—before you move to operational testing.
Why IQ Matters in GMP
IQ is where you prove the system was installed “as intended.” If installation is wrong—incorrect materials, wrong piping slope, missing filters, incorrect wiring, poorly placed sensors—then OQ/PQ results become unreliable. Regulators expect companies to show that installation is controlled, traceable, and documented to support a validated state.
Where IQ Is Used
- Production equipment (mixers, granulators, tablet presses, filling lines)
- Critical utilities (HVAC, purified water, clean steam, compressed gases)
- Laboratory instruments (HPLC, dissolution, balances—where qualification applies)
- Support systems (autoclaves, depyrogenation tunnels, CIP/SIP skids)
IQ vs Commissioning (Clear Difference)
- Commissioning: Technical set-up and basic functionality checks to make the system run as designed.
- IQ: GMP-documentation-driven verification that installation matches approved design/specs, with controlled evidence suitable for audits.
In many companies, commissioning activities can be leveraged to support IQ, but IQ must still be reviewed, approved, and documented under the quality system.
What an IQ Protocol Typically
- Scope and boundaries: what the IQ covers and what’s excluded
- Reference documents: URS, DQ, drawings (GA, P&ID), manuals, standards
- As-built verification: equipment tags, line labels, component IDs, installation matches drawings
- Materials of construction: product-contact materials, finishes, seals, gaskets, certificates
- Utilities verification: power, air, water, steam supply ratings and connections
- Instrument list and calibration status: sensors, gauges, transmitters, calibration due dates
- Software/firmware identification (if applicable): version numbers, access controls, backups
- Safety and compliance checks: guards, interlocks, grounding, pressure relief, safety labels
- Deviations and resolutions: documented issues, impact assessment, corrective actions
- Final conclusion: acceptance statement and readiness for OQ
Mini Example: What “As-Built” Evidence Looks Like
For a purified water loop, IQ evidence typically includes:
- Approved P&ID and verified installed piping route (as-built marking where needed)
- Material certificates (e.g., SS 316L), weld logs, passivation records (as applicable)
- Instrument list: conductivity, temperature, flow, pressure sensors with calibration status
- Filter housings, drain points, sample points and their tag identification
- Verification that slopes, deadlegs, and sanitary fittings match design intent
Common Confusions (Avoid These Audit Traps)
- Skipping drawing verification: Inspectors often ask, “Show me how you confirmed installation matches the P&ID.”
- Calibration gaps: If critical instruments aren’t calibrated before OQ, your OQ data becomes questionable.
- Missing certificates: Material/finish certificates and critical component traceability are frequent weak spots.
- “Pass by assumption”: “Vendor installed it” is not evidence; you need site verification and QA oversight.
Audit-Ready Talking Points
- Show the approved design basis (URS/DQ) and the installation evidence (as-built checks)
- Explain how critical components were identified and verified (risk-based approach)
- Demonstrate calibration control for critical instruments before OQ testing
- Show how deviations during installation were assessed, corrected, and closed
Quick IQ Checklist (Practical)
- All drawings and documents used are approved and current
- Equipment/system is tagged and matches the asset register
- Utilities are connected and meet specified ratings
- Critical components and materials have traceable certificates
- Critical instruments are identified and calibrated
- Safety features are installed and verified
- All IQ deviations are documented, assessed, and closed
FAQs
What is IQ used for in pharma?
IQ provides documented proof that installation is correct and matches approved specifications, so operational testing (OQ) can be trusted.
Can commissioning replace IQ?
No. Commissioning may generate supporting evidence, but IQ must be executed under the quality system with approved protocols, controlled records, and QA review.
What documents are commonly referenced in IQ?
URS, DQ, approved drawings (GA and P&ID), manuals, component specifications, calibration procedures, and relevant SOPs.
Do all instruments need calibration before OQ?
Critical instruments used to generate or interpret qualification data should be calibrated before OQ to protect data integrity and conclusions.
What is the most common IQ observation during audits?
Weak traceability—missing as-built checks, incomplete certificates, or unclear linkage between design requirements and installation evidence.