SOP for Monitoring Utility Validation Parameters – V 2.0

Procedure for Monitoring Utility Validation Parameters

Department	Quality Assurance (QA)/Validation/Engineering/Production
SOP No.	SOP/Ointment/146
Supersedes	V 1.0
Page No.	Page X of Y
Issue Date	[Insert Issue Date]
Effective Date	[Insert Effective Date]
Review Date	[Insert Review Date]

1. Purpose

The purpose of this Standard Operating Procedure (SOP) is to define a systematic approach for monitoring utility validation parameters in pharmaceutical manufacturing. Monitoring ensures that utilities such as HVAC, water systems, compressed air, and electrical supply remain compliant with regulatory requirements and maintain operational efficiency.

2. Scope

This SOP applies to all personnel in the Quality Assurance (QA), Validation, Engineering, and Production departments responsible for utility performance monitoring, data recording, and compliance assurance.

3. Responsibilities

QA Officer: Ensures compliance with monitoring protocols and records deviations.
Validation Team: Develops and updates monitoring criteria for utilities.
Engineering Team: Conducts utility system inspections, calibrations, and maintenance.
Production Supervisor: Ensures utilities maintain performance standards during production.
QA Manager: Reviews and approves utility performance reports.

4. Accountability

The QA and Engineering Managers are accountable for ensuring that utility validation monitoring is conducted as per GMP, FDA, ICH, and WHO guidelines.

5. Procedure

5.1 Identification of Critical Utility Parameters

The following utilities require continuous monitoring:

HVAC Systems: Temperature, humidity, pressure differentials, and airflow velocity.
Water Systems: Conductivity, microbial count, TOC levels, and endotoxin levels.
Compressed Air: Pressure stability, oil and moisture

content, and microbial contamination.

Electrical Utilities: Voltage stability, power fluctuations, and backup power availability.

5.2 Establishing Monitoring Frequency

Monitoring frequency should be established based on risk assessment and regulatory guidelines:

Continuous Monitoring: HVAC, water systems, electrical utilities.
Daily Monitoring: Water quality (pH, TOC), compressed air quality.
Weekly Monitoring: Filter integrity tests, differential pressure in cleanrooms.
Monthly Monitoring: Microbial contamination of utilities.

5.3 Monitoring Methodology

Use calibrated instruments for all parameter measurements.
Follow standard test methods (e.g., ISO 8573 for compressed air, USP for water quality).
Ensure real-time data logging for critical parameters.
Conduct manual readings where automated monitoring is not available.

5.4 Data Recording and Documentation

Record monitoring data in the Utility Performance Log.
Document readings in pre-approved formats to ensure traceability.
Use electronic systems where applicable for real-time monitoring.
Ensure all records are reviewed and approved by the QA team.

5.5 Handling Deviations

If utility parameters deviate from acceptance criteria:
- Investigate the cause and record findings.
- Initiate corrective and preventive actions (CAPA).
- Revalidate affected utilities before resuming production.
Maintain deviation reports for regulatory audits.

5.6 Routine Audits and Maintenance

Schedule periodic internal audits of utility monitoring records.
Ensure routine maintenance of HVAC, water, and compressed air systems.
Calibrate monitoring instruments at regular intervals.

6. Abbreviations

GMP – Good Manufacturing Practices
QA – Quality Assurance
HVAC – Heating, Ventilation, and Air Conditioning
TOC – Total Organic Carbon
CAPA – Corrective and Preventive Actions

7. Documents

Utility Performance Log (Annexure-1)
Utility Deviation Report (Annexure-2)

8. References

ICH Q7 – Good Manufacturing Practice Guide
ISO 8573-1: Compressed Air Purity Standards
USP Guidelines for Water Quality
WHO Guidelines for Utility Validation

9. SOP Version

Version 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Utility Performance Log

Date	Utility Type	Parameter Monitored	Recorded Value	Acceptance Criteria	Reviewed By
01/02/2025	HVAC	Room Temperature	22°C	20-24°C	QA Manager
02/02/2025	Water System	Conductivity	1.2 µS/cm	≤ 1.3 µS/cm	QA Manager

Annexure-2: Utility Deviation Report

Date	Utility Type	Deviation Observed	Root Cause	Corrective Action	Reviewed By
01/02/2025	Compressed Air	Excess Moisture Detected	Filter Saturation	Filter Replacement	QA Manager
02/02/2025	Electrical Supply	Voltage Fluctuation	Grid Instability	UPS Activation	QA Manager