1. Purpose

To establish a procedure for regular inspection of utilities (e.g., purified water, compressed air, HVAC system, steam, and gas supply) to ensure compliance with GMP requirements and operational efficiency.

2. Scope

This procedure applies to all utility systems used in the facility that may have direct or indirect impact on product quality.

3. Responsibilities

• Engineering Department: Perform inspections, record observations, and ensure timely rectification.

• Quality Assurance (QA): Review inspection records, verify compliance, and approve corrective actions.

• Production/Operations: Report any observed abnormalities.

4. Procedure

1. Water System (Purified Water / WFI)

   • Check storage and distribution tanks for cleanliness and integrity.

   • Verify temperature, conductivity, and TOC within limits.

   • Inspect pipelines for leaks or dead legs.

2. Compressed Air & Gases

   • Inspect filters and ensure differential pressure is within acceptable range.

   • Test for oil, moisture, and particulate contamination.

   • Ensure proper labeling of pipelines.

3. HVAC System

   • Inspect AHUs, ducts, and filters.

   • Check differential pressures between cleanroom areas.

   • Verify temperature, RH, and particle count compliance.

4. Steam System

   • Inspect steam traps and condensate lines.

   • Verify absence of corrosion or leakage.

   • Ensure clean steam supply quality is within pharmacopeial standards.

5. Electrical & Other Utilities

   • Inspect control panels, backup systems, and alarms.

   • Verify grounding and safety compliance.

5. Frequency

• Daily, weekly, monthly, or as per preventive maintenance schedule.

6. Documentation

• Record all observations in the Utility Inspection Logbook/Form.

• Deviations must be reported and corrected with CAPA.

7. References

• WHO GMP guidelines

• EU GMP Part 1 & Annexes

• ISPE Guidelines