1. Purpose

To establish a documented procedure to verify that the equipment/system has been properly installed according to manufacturer’s specifications, approved drawings, and regulatory requirements.

2. Scope

This SOP applies to all new equipment, instruments, utilities, and systems installed in the facility that require validation.

3. Responsibility

• Engineering Department – To install equipment as per approved specifications.

• Validation/QA Department – To prepare, review, and approve IQ protocols and reports.

• User Department – To assist in verification of installation and provide necessary support.

4. Procedure

1. Pre-requisites

   • Ensure that approved purchase order, vendor documents, and installation drawings are available.

   • Ensure utilities (electrical, compressed air, water, etc.) are available and suitable.

2. Verification Steps

   • Verify equipment name, model, serial number, and manufacturer details.

   • Verify installation as per approved layout and drawings.

   • Check utility connections and ratings (voltage, current, pressure, temperature).

   • Verify critical components, assemblies, and calibration certificates of instruments.

   • Confirm availability of manuals (operation, maintenance, service).

   • Verify compliance with cGMP and safety requirements.

3. Documentation

   • Record observations in the IQ protocol.

   • Attach calibration certificates, drawings, and checklists.

   • Document deviations (if any) and corrective actions taken.

4. Approval

   • Submit IQ report to QA for review.

   • Obtain final approval from QA and department head.

5. References

• WHO TRS guidelines

• EU GMP Annex 15 (Qualification and Validation)

• US FDA Guidance for Industry

6. Abbreviations

• IQ: Installation Qualification

• OQ: Operational Qualification

• PQ: Performance Qualification

• SOP: Standard Operating Procedure