SOP Guide for Pharma

Aerosol: SOP for Verifying Utility System Performance During Process Changes – V 2.0

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Aerosol: SOP for Verifying Utility System Performance During Process Changes – V 2.0

SOP for Verifying Utility System Performance During Process Changes

Department Aerosol
SOP No. SOP/Aerosol/149/2025
Supersedes SOP/Aerosol/149/2022
Page No. Page 1 of Y
Issue Date 06/02/2025
Effective Date 16/02/2025
Review Date 06/02/2028

1. Purpose

The purpose of this Standard Operating Procedure (SOP) is to establish a process for verifying the performance of utility systems during process changes in aerosol manufacturing. Any changes made to the manufacturing process may affect the performance of utility systems such as water, compressed air, gas, and HVAC systems. This SOP ensures that the performance of these systems is re-verified after process changes to confirm that they continue to meet the necessary specifications for safe and efficient production.

2. Scope

This SOP applies to all utility systems used in aerosol manufacturing, including water systems, compressed air systems, gas systems, and HVAC systems. The scope includes the verification of utility system performance following process changes, such as changes in production requirements, modifications to equipment, or regulatory updates, to ensure that the systems continue to function within the required operational parameters.

3. Responsibilities

4. Accountability

The Manufacturing Manager is accountable for ensuring that the utility system verification process is performed after any process changes. The overall compliance with this SOP is overseen by the Quality Assurance (QA) Manager.

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5. Procedure

5.1. Preparing for Verification of Utility System Performance

  1. Review the process change details and identify which utility systems may be impacted by the change. This may include changes in production requirements, equipment modifications, or regulatory updates.
  2. Ensure that all necessary equipment for verifying utility system performance is available and calibrated. This includes pressure gauges, flow meters, temperature sensors, and any other testing instruments required for performance verification.
  3. Establish the verification team, which should include representatives from Engineering, Production, and QA teams. All personnel involved in the verification process should be trained in the relevant procedures and standards.
  4. Determine the specific performance parameters for each utility system that need to be verified following the process change. These may include pressure, flow rates, temperature, contamination levels, and system integrity.

5.2. Verifying Utility System Performance

  1. The verification process should include the following key steps for each affected utility system:
    • Water Systems: Verify that water flow rates, pressure, and temperature are within the acceptable ranges. Perform microbial and particulate testing to ensure that water quality is maintained.
    • Compressed Air Systems: Verify that the compressed air pressure and flow rate are within the specified limits. Perform contamination testing to ensure that no particulate matter or oil is present in the system.
    • Gas Systems: Verify that gas pressure and flow rates are within the required ranges. Perform gas purity testing to ensure that no contaminants are present in the gas supply.
    • HVAC Systems: Verify that the HVAC system is maintaining the required temperature and humidity levels. Perform airflow and filtration efficiency testing to ensure compliance with the specifications.
  2. Perform the necessary tests for each system under normal operating conditions to confirm that the system continues to meet the required performance standards after the process change.
  3. Record all test results, including pressure readings, flow rates, temperature, contamination levels, and any deviations observed during testing. Document the results in the Utility Performance Verification Report (Annexure-1).
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5.3. Documenting the Verification Results

  1. Document the following information in the Utility Performance Verification Report (Annexure-1):
    • Utility system ID, model number, serial number, and installation location
    • Details of the process change and its potential impact on utility systems
    • The test methods, results, and comparison with acceptable limits
    • Any deviations observed and corrective actions taken
    • The name and signature of the personnel performing the verification tests
    • Approval signatures from the QA team
  2. Ensure that all data entries are legible, accurate, and supported by the necessary calibration and testing equipment used during the verification process.

5.4. Reviewing and Approving the Verification Report

  1. The QA team should review the Utility Performance Verification Report to ensure that all verification activities were carried out according to SOP requirements, and that the utility systems are performing within the required specifications.
  2. If any deviations are found, they should be documented in the Deviation Log (Annexure-2), and corrective actions should be taken to address the issues.
  3. Once the verification report is complete and all deviations have been addressed, the QA team should approve the report.

5.5. Finalizing the Verification Process

  1. After the verification process is completed and the utility systems are confirmed to be operating within the specified parameters, the systems are cleared for use in the production process.
  2. Ensure that all verification documentation, including the Utility Performance Verification Report, Deviation Log, and Corrective Action Log, is archived for future audits and inspections.
  3. Periodic verification of utility systems should be scheduled, based on the specific process change or as required by regulatory authorities, to ensure continued compliance with operational standards.
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6. Abbreviations

7. Documents

  1. Utility Performance Verification Report (Annexure-1)
  2. Deviation Log (Annexure-2)
  3. Corrective Action Log (Annexure-3)

8. References

This SOP is based on the following regulatory guidelines and industry standards:

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 Verification Report

System ID Model Number Serial Number Test Date Test Type Result
Water-001 Model A SN123456 06/02/2025 Flow Rate Test Pass
Air-002 Model B SN987654 06/02/2025 Pressure Test Pass

Annexure-2: Deviation Log

Deviation ID Deviation Description Corrective Action Assigned To Status
DEV-12345 Pressure deviation during flow rate test Adjusted pressure regulator Rajesh Patel Completed

Annexure-3: Corrective Action Log

Action ID Action Description Responsible Person Completion Date
CA-12345 Recalibrated pressure regulator Rajesh Patel 06/02/2025

12. Revision History:

Revision Date Revision No. Revision Details Reason for Revision Approved By Page No. Ref. Point No. Details of Revision
01/01/2024 V 1.0 Initial Release First Issue Anjali Sharma Page 1 [Ref Point] First Release
01/01/2025 V 2.0 Updated performance verification procedures To comply with updated GMP regulations Anjali Sharma Page 1 [Ref Point] Updated procedures
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