Installation Qualification

The data collected during the Installation Qualification can be packaged and summarized either individually or as part of an IQ/OQ/PQ package for presentation, review, and approval.

The Installation Qualification Protocol provides a systematic method to check the system/equipment static attributes prior to normal operation. A detailed description of the system should be included as a part of IQ. This description includes all important major/minor components of the system.

The availability of the applicable SOPs must be verified. These include system/equipment operation, maintenance, cleaning and/or sanitization.

The system should be reviewed after installation to verify that the it is confirms to its design specifications. Engineering drawings, manuals, data sheets, and purchase orders can be used to document proper installation and placement. These documents should be refered in the protocol.

The system’s support utilities (e.g., water, steam, electric, etc.)installation must be evaluated for proper connection and installation of supporting services and components (e.g., filters, piping, valves, gauges, controls, etc.)

Calibration scope for control, monitoring, and recording instrumentation (e.g., pressure gauges, temperature sensors, timers, etc.) that could impact product integrity, quality, or efficacy has to be defined in scope of IQ.

Any exceptional conditions encountered during the IQ that could impact process integrity or product reproducibility, are identified, investigated, and documented (including justification, correction, and any necessary re-qualification studies)

Installation qualification requirements for equipment include checking for proper location, proper energy supply and acceptable environmental conditions. There is also checking of contents against the packing list, verifying software installation, documenting computer-controlled instrumentation, verifying connections with peripherals, and recording calibration and validation dates, among others.

Step by Step IQ Procedure :

1. Identification of Major Components / Accessories,

2. Installation Check / Review,

3. Inspection Check / Review,

4. Identification, Classification, Verification of Process Control Instruments,

5. Identification & Verification of MOC,

6. Identification & Verification of Supporting Utilities,

7. Identification & Verification of Supporting Documents,

8. Deviation & Corrective Action Report,

9. Conclusion,

10. Installation Qualification Approval.

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