Aerosol: SOP for Revalidating Equipment After Maintenance – V 2.0

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Aerosol: SOP for Revalidating Equipment After Maintenance – V 2.0

SOP for Revalidating Equipment After Maintenance

Department Aerosol
SOP No. SOP/Aerosol/139/2025
Supersedes SOP/Aerosol/139/2022
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 outline the process for revalidating aerosol manufacturing equipment after maintenance activities. Revalidation ensures that the equipment continues to perform within specified parameters and meets quality standards after any maintenance, repair, or modification. This SOP ensures that equipment remains compliant with Good Manufacturing Practices (GMP) and regulatory requirements post-maintenance.

2. Scope

This SOP applies to all aerosol manufacturing equipment that undergoes maintenance, including filling machines, crimping machines, mixing tanks, and other related equipment. It covers the revalidation process following maintenance activities, such as routine servicing, repairs, calibration, or modifications that may impact the equipment’s performance.

3. Responsibilities

  • Engineering Team: Responsible for conducting revalidation tests after maintenance, ensuring that all equipment parameters are restored to their intended specifications.
  • Maintenance Team: Responsible for performing the maintenance activities on equipment and ensuring that it is ready for revalidation once maintenance is complete.
  • Production Team: Responsible for assisting with the revalidation process, ensuring that equipment is operating correctly during production, and reporting any deviations.
  • Quality Assurance (QA) Team: Responsible for reviewing and approving the revalidation process and ensuring that all test results, deviations, and corrective actions are documented and compliant with regulatory requirements.

4. Accountability

The Manufacturing Manager is accountable for ensuring that revalidation of equipment after maintenance is performed in compliance with this SOP. The overall compliance with this SOP is overseen by the Quality Assurance (QA) Manager.

5. Procedure

5.1. Preparing for Revalidation

  1. Ensure that the equipment has undergone the necessary maintenance or repair work and is restored to full functionality. This may include cleaning, calibration, component replacement, or adjustments to machine settings.
  2. Review the maintenance records to ensure that the equipment was serviced according to the manufacturer’s instructions or internal SOPs.
  3. Confirm that all necessary tools and resources for revalidation (e.g., calibration equipment, testing instruments, test materials) are available and ready for use.
  4. Verify that any new components, parts, or software installed during maintenance have been properly tested for compatibility and compliance with operational standards.
  5. Establish the revalidation team, which should include members from the Engineering, Production, and QA teams. Ensure that the personnel involved are trained on revalidation procedures and equipment specifications.
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5.2. Conducting the Revalidation

  1. Revalidation testing should be conducted in the same manner as the initial qualification or after significant modifications. The following tests should be performed:
    • Functional Test: Verify that the equipment operates according to the specifications defined during the initial qualification process. This includes checking for any changes in machine speed, pressure, temperature, or other critical parameters.
    • Performance Test: Perform the same tests used during the original Operational Qualification (OQ) and Performance Qualification (PQ) to verify that the equipment produces consistent and reliable results. For example, check filling accuracy, crimping consistency, or mixing efficiency, as applicable.
    • Calibration Test: If any components were calibrated or adjusted during maintenance, ensure that the calibration is verified against a known standard. For example, calibrate temperature sensors, pressure gauges, or other measurement instruments used by the equipment.
    • Safety Test: Verify that all safety features are working correctly, such as emergency stops, alarms, or protective shields, and that they have not been impacted by the maintenance activities.
    • System Integration Test: If the equipment is connected to a larger system (e.g., automated control systems, data collection systems), verify that the integration is functioning as expected, with no data discrepancies or communication failures.
  2. During testing, record all test results, including the test conditions, measurements, and any deviations observed. Document the results in the Equipment Revalidation Report (Annexure-1).
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5.3. Documenting the Revalidation Results

  1. Document the following information in the Equipment Revalidation Report (Annexure-1):
    • Equipment ID, model number, serial number, and location
    • Details of the maintenance activities performed on the equipment
    • Test methods and acceptance criteria used during revalidation
    • The results of each test performed, including any deviations or non-conformities
    • Corrective actions taken if any deviations are observed during the revalidation process
    • The name and signature of the personnel who performed the revalidation tests
    • The approval signatures from the QA team
  2. Ensure that the revalidation report is signed by the responsible personnel and reviewed by the QA team for accuracy and completeness.

5.4. Reviewing and Approving the Revalidation Report

  1. The QA team should review the Equipment Revalidation Report to ensure that the equipment meets the required specifications after maintenance and that all tests were conducted in compliance with the validation protocol.
  2. If any deviations are identified during revalidation, they should be documented in the Deviation Log (Annexure-2). Corrective actions should be implemented, and the tests should be repeated to verify the effectiveness of the corrective actions.
  3. The QA team should approve the report once all revalidation activities are complete and any deviations have been addressed.

5.5. Finalizing the Revalidation Process

  1. Once the equipment has been successfully revalidated, it is considered ready for use in regular production. The equipment can be returned to service.
  2. All documentation, including the Equipment Revalidation Report, Deviation Log, and any corrective actions, should be archived for future audits and inspections.
  3. Periodic revalidation should be scheduled, as needed, to ensure that the equipment continues to perform within the required specifications after any future maintenance or repairs.
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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. Equipment Revalidation 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
  • International Council for Harmonisation (ICH) Guidelines

9. SOP Version

Version: 2.0

10. Approval Section

Prepared By Checked By Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Equipment Revalidation Report

Equipment ID Model Number Serial Number Test Date Test Type Result
FILL-001 Model A SN123456 06/02/2025 Revalidation Test Pass
FILL-001 Model A SN123456 06/02/2025 Performance Test Pass

Annexure-2: Deviation Log

Deviation ID Deviation Description Corrective Action Assigned To Status
DEV-12345 Temperature deviation during testing Recalibrated temperature control system Rajesh Patel Completed

Annexure-3: Corrective Action Log

Action ID Action Description Responsible Person Completion Date
CA-12345 Recalibrated temperature control 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 revalidation procedures To comply with updated GMP regulations Anjali Sharma Page 1 [Ref Point] Updated procedures
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