SOP Guide for Pharma

Aerosol: SOP for Maintaining Equipment Logbooks in Aerosol Manufacturing – V 2.0

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Aerosol: SOP for Maintaining Equipment Logbooks in Aerosol Manufacturing – V 2.0

SOP for Maintaining Equipment Logbooks in Aerosol Manufacturing

Department Aerosol
SOP No. SOP/Aerosol/152/2025
Supersedes SOP/Aerosol/152/2022
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 maintaining equipment logbooks in aerosol manufacturing. Proper documentation of equipment usage, maintenance, and calibration is essential to ensure that manufacturing equipment operates efficiently and in compliance with regulatory standards. This SOP provides guidelines for creating, updating, and maintaining equipment logbooks to support manufacturing quality, safety, and traceability.

2. Scope

This SOP applies to all manufacturing equipment used in aerosol production, including mixers, filling machines, crimping machines, and HVAC systems. It covers the procedures for maintaining equipment logbooks, which include documenting routine maintenance, calibration, repairs, and any issues encountered during equipment operation.

3. Responsibilities

4. Accountability

The Manufacturing Manager is accountable for ensuring that equipment logbooks are properly maintained and that all necessary records are up-to-date. The overall compliance with this SOP is overseen by the Quality Assurance (QA) Manager.

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5. Procedure

5.1. Preparing the Equipment Logbook

  1. Each piece of manufacturing equipment should have its own logbook. The logbook should be assigned a unique identification number that corresponds to the equipment’s serial number or equipment ID.
  2. The logbook should include the following sections:
    • Equipment ID, model number, and serial number
    • Manufacturer information and equipment specifications
    • Initial installation and commissioning details
    • Calibration schedule and records
    • Maintenance schedule and records
    • Repairs and modifications
    • Performance history, including any malfunctions or deviations
  3. Ensure that the logbook is easily accessible and properly stored to prevent unauthorized access. It should be kept in a secure location in the production area or a designated equipment storage room.

5.2. Updating the Equipment Logbook

  1. Update the equipment logbook each time maintenance, calibration, or repairs are performed. For each entry, include the following:
    • Date of activity
    • Type of activity (e.g., maintenance, calibration, repair)
    • Details of the work performed
    • Names and signatures of personnel who performed the activity
    • Any observations or issues encountered
    • Results of any tests or inspections performed
  2. If the equipment is taken out of service for repairs, document the reasons for the downtime and any corrective actions taken. Once repairs are complete, the equipment should be tested to ensure it meets the required performance standards, and the results should be recorded in the logbook.
  3. For routine maintenance, refer to the equipment manufacturer’s recommended maintenance schedule. This schedule should be followed unless otherwise specified by the equipment’s performance during operation or any regulatory requirements.
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5.3. Performing Calibration and Verification

  1. Ensure that calibration of equipment is performed according to the approved calibration schedule, which is based on manufacturer recommendations, industry standards, and regulatory requirements.
  2. Record the calibration results, including:
    • Calibration date
    • Calibration standard used
    • Calibration results and any adjustments made
    • Names and signatures of personnel performing the calibration
  3. If the equipment does not pass the calibration, document the corrective actions taken to bring it back into compliance and verify that the equipment is functioning correctly after the corrective action.

5.4. Reviewing the Equipment Logbook

  1. Conduct periodic reviews of equipment logbooks to ensure that they are being maintained properly and that all required entries are made. This includes checking the completeness of the maintenance, calibration, and repair records.
  2. Ensure that all deviations, failures, or issues with equipment are documented accurately and addressed with corrective actions. Any unresolved issues should be escalated to the QA team for further investigation.
  3. The QA team should review the logbooks regularly to ensure that they meet regulatory and company requirements and that all required documentation is in place. Any discrepancies or missing records should be addressed immediately.

5.5. Archiving the Equipment Logbook

  1. After the equipment is decommissioned or replaced, the logbook should be archived for historical reference and regulatory compliance. The logbook should be stored for the required period as per regulatory guidelines or company policy.
  2. Ensure that all archived logbooks are stored in a secure and organized manner to ensure easy retrieval during audits, inspections, or any investigations.
  3. Once the retention period for the logbook has passed, ensure that it is disposed of securely, in accordance with company policies for document destruction.
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6. Abbreviations

7. Documents

  1. Equipment Logbook (Annexure-1)
  2. Calibration Record (Annexure-2)
  3. Maintenance Log (Annexure-3)
  4. Deviation Log (Annexure-4)

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: Equipment Logbook

Equipment ID Model Number Serial Number Last Maintenance Date Maintenance Performed Performed By
FM-001 Model X SN123456 06/02/2025 Lubrication and inspection Rajesh Patel

Annexure-2: Calibration Record

Equipment ID Calibration Date Calibration Standard Result Performed By
FM-001 06/02/2025 ISO 9001 Pass Rajesh Patel

Annexure-3: Maintenance Log

Equipment ID Maintenance Date Type of Maintenance Details of Maintenance Performed By
FM-001 06/02/2025 Preventive Checked filters, cleaned equipment Rajesh Patel

Annexure-4: Deviation Log

Deviation ID Description Corrective Action Responsible Person Status
DEV-12345 Filling machine malfunction Recalibrated machine Rajesh Patel Completed

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