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 |