Installation Qualification (IQ) Protocol — Glass-Lined
Reactor (GLR)
1. Document Control
Title: Installation Qualification Protocol – Glass-Lined Reactor
Document Number: [e.g., IQ-GLR-001]
Version: [e.g., v1.0]
Prepared by / Reviewed by / Approved by: Include names, roles, and dates
Revision History: Log of version updates and changes
2. Objective & Purpose
Ensure the GLR and all associated systems are installed per design specifications,
manufacturer guidelines, and user requirements. This is critical before progressing to
Operational and Performance Qualification.
3. Scope
Covers the GLR unit with its major components—agitator, utilities (steam, cooling water,
vacuum, electrical), instrumentation, and documentation. Defines boundaries including
connected systems and excluded areas.
4. System Description
Provide a concise description:
Reactor capacity, model, serial number, location
Configuration: vessel, jacket, agitator, instrumentation
Utility connections
Also include referencing documentation (URS, GA drawings, P&ID, supplier specs).
5. References
URS and DQ documentation
Manufacturer manuals, drawings, P&IDs, instrument lists
Regulatory and validation standards (e.g., EU GMP Annex 15)
6. Prerequisites
Before IQ execution:
Approved validation master plan and IQ protocol
All required documentation and materials available
Personnel trained and briefed
7. Procedure and Checklist Components
7.1 Equipment Identification
Verify nameplate data: serial number, model, manufacturer—against documentation
7.2 Documentation Review
Manuals, calibration certificates, P&IDs, GA drawings verified
Ensure documentation completeness and compliance
7.3 Installation Verification
Confirm reactor and accessories installed per drawings
Check alignment, mounting, and structural support quality
7.4 Utilities Verification
Ensure proper connection of steam, cooling water, vacuum, electrical, compressed air,
and grounding
Confirm piping, wiring, and labeling accuracy
7.5 Instrumentation & Calibration
Check all sensors, gauges, and instruments are installed, accessible, and calibrated
(with traceable certificates)
7.6 Environmental and Safety Conditions
Validate installation area conditions—temperature, lighting, clearances—are met
Confirm safety provisions (e.g., emergency stops) are in place
7.7 Spare Parts & Consumables
Verify availability of listed spare parts and consumables; ensure replenishment
strategy is defined
7.8 Personnel Training
Confirm installation team has adequate training and qualifications to perform
installation and IQ
8. Acceptance Criteria
Each checklist entry should specify expected vs. actual, with clear pass/fail criteria—for
example:
Serial number matches documented records
Utilities connected and pressure within design limits
Instruments calibrated and certificates on file
Deviation handling must be documented with root cause analysis and corrective actions.
9. Deviation & Change Control
Document all deviations during IQ execution
Evaluate potential impact and apply corrective actions
Follow change control procedures for any amendments
10. Protocol Execution & Sign-offs
Log completion dates, test results, signatures of responsible personnel
QA to review and approve the executed IQ protocol report
11. Appendices
Include:
IQ check sheets for each verification area (e.g., utilities, instrumentation, installation
integrity)
Calibration certificates, instrument tags, P&ID snapshots
Deviation log and investigation reports
Summary Table: IQ Protocol Outline
Section Description
Document Control Title, version, prepared/reviewed/approved by, revision history
Objective Ensure correct installation per specifications before OQ/PQ
Scope GLR and associated systems within qualification boundary
System Description Configuration, location, specifications, documentation references
References URS, DQ, GMP Annex 15, vendor/manual/piping and instrumentation
Section Description
drawings
Prerequisites Training, documentation, protocol approval
Equipment, documentation, installation, utilities, instruments,
Verification Steps
environment
Acceptance Criteria Defined expected results with pass/fail benchmarks
Deviations &
Logging and resolution of deviations, implementation of change control
Change
Execution & Sign-
Report execution, review, QA approval
off
Appendices Supporting documentation, check sheets, deviation logs
