Published on 07/12/2025
How to Perform Installation Qualification (IQ) in Pharma: Step-by-Step Guide to Verifying Equipment Installation
Installation Qualification (IQ) is the documented verification that equipment, instruments, or systems have been delivered, installed, and configured in accordance with approved design specifications and GMP requirements. As the first stage in the Equipment Qualification lifecycle (IQ → OQ → PQ), IQ plays a foundational role in ensuring that all future operations rest on a compliant and verified installation.
This tutorial-style article provides QA, QC, validation, and regulatory professionals with an end-to-end guide to IQ execution—including protocols, checklist items, supporting documentation, and real-world compliance expectations as per FDA, EMA, and ICH Q8-Q10 guidance.
What Is Installation Qualification (IQ)?
IQ confirms that all components of an equipment or system are:
- Installed correctly according to manufacturer’s instructions
- Located as per layout drawings and specifications
- Properly connected to utilities (electrical, HVAC, water, etc.)
- Supplied with all required documentation and calibration records
- Identified uniquely with asset/equipment IDs and tags
IQ must be executed and approved before moving to Operational Qualification (OQ). It ensures that the equipment is physically and functionally ready for qualification and operation.
IQ vs. FAT, SAT, and OQ: Understanding the Boundaries
While
- FAT: At vendor site, before shipment
- SAT: At user site, initial startup verification
- IQ: GMP-compliant, documented, audited step verifying installation
- OQ: Functional performance testing post-installation
Key Components of an IQ Protocol
An IQ protocol is a pre-approved document defining the tests, inspections, and documentation checks needed to verify equipment installation. Core sections include:
- Protocol Approval Sheet (QA, Engineering, Validation sign-offs)
- Equipment Description and Identification
- Reference Documents and Applicable SOPs
- List of Materials and Components Received
- Verification of Installation (as per approved drawings)
- Utility Connection Checks (voltage, air, drain, water)
- Calibration and Certificate Verification
- Lubrication, Safety, and Grounding Confirmation
- Spare Parts and Tool Availability
- Deviation Handling and Remarks Section
- Final Summary and Conclusion Page
Step-by-Step IQ Execution Process
Step 1: Equipment Receipt and Identification
- Verify delivery note matches purchase order
- Check packaging integrity
- Assign Equipment ID and location code
- Label with GMP-compliant tags
Step 2: Cross-Check with Design and Layout Drawings
- Review P&ID diagrams (if applicable)
- Match dimensions, location, and orientation
- Photographic documentation of actual installation
Step 3: Verification of Mechanical Installation
Inspect the installation of mechanical parts (valves, agitators, vessels) and verify as per vendor documentation and equipment manual.
Step 4: Utility Connection Verification
Check all connections (electrical, pneumatic, hydraulic, steam, etc.). Ensure compatibility with plant infrastructure.
| Utility | Required Specification | Connected Specification | Status |
|---|---|---|---|
| Electric Supply | 230V, 50Hz | 230V, 50Hz | ✓ |
| Compressed Air | 6 bar | 6.1 bar | ✓ |
| Water Drain | 1-inch outlet | 1-inch | ✓ |
Step 5: Calibration and Certificate Verification
- Review calibration certificates for instruments and sensors
- Verify calibration date, range, traceability (e.g., to NIST)
- Record serial numbers, due dates, and calibration status
Step 6: Safety and Compliance Checks
- Earth/Grounding resistance measurement
- Safety interlocks testing (emergency stops)
- Presence of safety guards and enclosures
Step 7: Review of Supporting Documentation
- User and Maintenance Manuals
- As-built drawings (mechanical, electrical)
- SOP references and standard checklists
- Spare parts and bill of materials
Step 8: Deviations and Non-Conformance Management
If any step fails or does not comply with predefined criteria, raise a deviation with root cause analysis (RCA) and CAPA. Close deviation before final approval.
Example IQ Test Record Template
| Test Description | Expected Result | Actual Result | Status |
|---|---|---|---|
| Electrical Supply Match | 230V, 50Hz | 230V, 50Hz | Pass |
| Calibration Certificate | Valid ≤ 12 months | Valid | Pass |
| Grounding Resistance | < 1.0 ohm | 0.6 ohm | Pass |
Regulatory and Industry Guidelines for IQ
- FDA Process Validation Guidance
- EMA Annex 15 – Qualification and Validation
- ICH Q8, Q9, Q10
- WHO TRS 986 Annex 3
Common Mistakes in IQ and How to Avoid Them
- Not verifying serial numbers and tag IDs
- Missing calibration certificates or expired ones
- Utility mapping not properly documented
- Failure to handle deviations through formal CAPA
- Incomplete final summary and QA sign-off
Conclusion
Installation Qualification (IQ) is the starting point for demonstrating GMP compliance of new or modified pharmaceutical equipment. A robust IQ ensures that equipment is installed according to specifications and is supported by proper documentation, utility connections, safety verifications, and traceability. When properly executed and documented, IQ becomes the foundation for reliable operations and regulatory confidence throughout the equipment lifecycle.
For downloadable IQ protocol templates, master plans, and sample checklists, visit PharmaSOP.in or explore deeper validation lifecycle strategies at PharmaValidation.in.