Aerosol: SOP for Periodic Requalification of Utility Systems – V 2.0

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Aerosol: SOP for Periodic Requalification of Utility Systems – V 2.0

SOP for Periodic Requalification of Utility Systems

Department Aerosol
SOP No. SOP/Aerosol/148/2025
Supersedes SOP/Aerosol/148/2022
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 define the process for the periodic requalification of utility systems in aerosol manufacturing. The validation and requalification of utility systems, such as water, air, compressed gases, and HVAC, are essential for maintaining the required operational standards and ensuring compliance with Good Manufacturing Practices (GMP). Periodic requalification ensures that utility systems continue to perform as expected and meet the necessary specifications for product quality and safety.

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 procedure covers the requalification of these systems, which occurs periodically or after any significant modifications or changes to system components, operation, or regulations that may affect their performance.

3. Responsibilities

  • Engineering Team: Responsible for carrying out the requalification of utility systems, ensuring that all systems are operating within the required parameters and specifications.
  • Maintenance Team: Responsible for ensuring that the utility systems are in good working condition before requalification and supporting any repairs or maintenance required during the requalification process.
  • Quality Assurance (QA) Team: Responsible for reviewing, approving, and ensuring the accuracy of all requalification documentation. The QA team ensures that the systems meet regulatory standards and internal specifications.
  • Production Team: Responsible for reporting any system issues that may affect manufacturing and for ensuring the utility systems operate properly during production cycles.
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4. Accountability

The Manufacturing Manager is accountable for ensuring that all utility systems are requalified according to this SOP. The overall compliance with this SOP is monitored by the Quality Assurance (QA) Manager.

5. Procedure

5.1. Preparing for Periodic Requalification

  1. Review the specifications and operational parameters for the utility systems to be requalified. This includes checking for any recent maintenance, repairs, or modifications that could impact system performance.
  2. Ensure all requalification testing equipment, such as pressure gauges, flow meters, temperature sensors, and calibration tools, are available and properly calibrated for testing.
  3. Verify that all necessary documentation is in place, including previous qualification records, maintenance logs, and system design specifications.
  4. Establish a requalification team that includes personnel from Engineering, Maintenance, Production, and QA. All team members should be trained in the requalification process and standards.

5.2. Conducting the Periodic Requalification

  1. The requalification process includes the following key activities:
    • Installation Qualification (IQ): Verify that the utility system is installed correctly according to the design specifications, ensuring that all components are functioning as intended.
    • Operational Qualification (OQ): Confirm that the system operates correctly under normal operational conditions. This includes testing critical parameters such as pressure, flow rates, and temperature to ensure they are within the specified limits.
    • Performance Qualification (PQ): Verify that the system performs consistently over time and under actual operating conditions, meeting the required specifications without deviation.
    • System Integrity Test: Ensure that the system does not have leaks or failures that could impact performance. This includes testing pressure retention, flow rates, and confirming system integrity across all components.
    • Contamination Control Test: Verify that the utility system does not introduce contaminants into the production process. This includes testing for microbial contamination, particulate matter, and any other potential impurities.
  2. During the requalification, ensure that all performance tests are conducted under normal production conditions to verify that the utility systems can reliably meet operational demands.
  3. Record all test results, including pressure readings, flow rates, temperatures, and any deviations from expected performance. This documentation should be included in the Utility Requalification Report (Annexure-1).
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5.3. Documenting the Requalification Results

  1. Document all requalification results in the Utility Requalification Report (Annexure-1). The report should include:
    • System ID, model number, serial number, and location
    • Test methods, results, and comparison with acceptable ranges
    • Any deviations or non-conformities observed during testing and any corrective actions taken
    • The names and signatures of the personnel performing the requalification
    • Approval signatures from the QA team
  2. Ensure that all test results are clearly documented and that any discrepancies or issues are addressed and documented with corrective actions.

5.4. Reviewing and Approving the Requalification Report

  1. The QA team should review the Utility Requalification Report for completeness and accuracy, ensuring that the requalification process was carried out according to SOP requirements and that the system meets all regulatory and operational standards.
  2. If any deviations are found, document them in the Deviation Log (Annexure-2) and perform corrective actions to resolve the issue. Ensure that any deviations are addressed before the report is approved.
  3. Once all corrective actions are complete and the report is finalized, the QA team should approve the requalification report.

5.5. Finalizing the Requalification Process

  1. After the utility system passes requalification, it is considered qualified and may be used for production without restrictions. Ensure that the system is clearly labeled with the requalification date and the next due date for requalification.
  2. Archive all requalification documentation, including the Utility Requalification Report, Deviation Log, and any Corrective Action Reports, for future audits and inspections.
  3. Schedule periodic requalification according to regulatory requirements or after significant system changes or maintenance, ensuring the system remains in a qualified state.
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6. Abbreviations

  • GMP: Good Manufacturing Practice
  • QA: Quality Assurance
  • SOP: Standard Operating Procedure
  • CAPA: Corrective and Preventive Action
  • OQ: Operational Qualification
  • PQ: Performance Qualification
  • IQ: Installation Qualification

7. Documents

  1. Utility Requalification 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:

  • Good Manufacturing Practice (GMP) Guidelines
  • FDA Code of Federal Regulations (CFR) Title 21, Part 211
  • ISO 9001 – Quality Management Systems

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 Requalification 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 requalification procedures To comply with updated GMP regulations Anjali Sharma Page 1 [Ref Point] Updated procedures
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