SOP Guide for Pharma

Creams: SOP for Documentation of Machine Operations in Cream Production – V 2.0

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Creams: SOP for Documentation of Machine Operations in Cream Production – V 2.0

Standard Operating Procedure for Documentation of Machine Operations in Cream Production

Department Creams
SOP No. SOP/CRM/119/2025
Supersedes SOP/CRM/119/2022
Page No. Page 1 of 5
Issue Date 21/01/2026
Effective Date 26/01/2026
Review Date 21/01/2027

1. Purpose

The purpose of this SOP is to define the procedure for documenting machine operations during cream production. Proper documentation ensures compliance with GMP standards, facilitates traceability, and enables quick identification of any deviations or issues during production.

2. Scope

This SOP applies to all machines used in the cream production process, including homogenizers, mixers, filling machines, and other production equipment. It covers the documentation of operational parameters, maintenance activities, and any deviations during production.

3. Responsibilities

4. Accountability

The Production Supervisor is accountable for ensuring that all machine operation parameters are documented correctly. The Maintenance Supervisor is responsible for ensuring that all maintenance activities are documented accurately, and the Quality Control Manager is responsible for reviewing and approving documentation.

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5. Procedure

5.1 Pre-Operation Documentation

  1. Before the start of production, verify that all machines are properly calibrated and in good working condition. Check the equipment manual to ensure that the machine is set to the correct parameters for the current production run.
  2. Document the machine’s ID, the current batch number, and the operator’s name in the Machine Operations Log (Annexure-1).
  3. Record the set parameters, including the desired temperature, speed, and mixing time, as specified in the product’s manufacturing formula or SOP.
  4. Ensure that the machine’s safety features (e.g., emergency stop, alarms) are functioning properly and document these checks in the Machine Safety Check Log (Annexure-2).

5.2 In-Process Documentation

  1. During production, monitor the machine’s performance and record operational parameters at regular intervals. This includes recording the following:
    • Mixing speed (RPM)
    • Temperature
    • Time (e.g., mixing or processing duration)
    • Pressure (if applicable)
  2. Use the Machine Operations Log (Annexure-1) to document the values for each parameter at least every 30 minutes during operation or as per the defined process guidelines.
  3. If the machine is equipped with automated monitoring systems (e.g., sensors or temperature controllers), ensure that these systems are functioning correctly and that the data is recorded automatically.
  4. In the case of any deviation from the established parameters, document the deviation in the Deviation Log (Annexure-3) and notify the Production and QC Managers for investigation.

5.3 Post-Operation Documentation

  1. After the production run is complete, document the final operational parameters in the Machine Operations Log (Annexure-1), including the total operating time and any observed abnormalities.
  2. Record any maintenance performed on the machine during the shift in the Equipment Maintenance Log (Annexure-4). This includes cleaning, repairs, or adjustments made to the machine during production.
  3. Ensure that the equipment is properly shut down, cleaned, and stored according to the manufacturer’s guidelines. Document the shutdown process in the Equipment Shutdown Log (Annexure-5).
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5.4 Deviation Handling and Corrective Actions

  1. If any deviations from the specified parameters are observed, stop production immediately and document the issue in the Deviation Log (Annexure-3).
  2. Investigate the cause of the deviation, which may include malfunctioning equipment, incorrect settings, or operator error.
  3. Take corrective actions to resolve the deviation, such as adjusting the machine settings, replacing defective parts, or recalibrating equipment.
  4. Once corrective actions have been taken, document the changes and re-verify that the machine is operating within the specified parameters. Resume production only after ensuring that the issue is fully resolved.

5.5 Documentation Review and Record-Keeping

  1. All documentation related to machine operations must be reviewed and signed off by the Quality Control team to ensure that it complies with GMP standards.
  2. Maintain machine operation logs, deviation logs, maintenance records, and shutdown logs for each batch produced. These records should be stored securely and kept accessible for audits and inspections.
  3. Ensure that records are retained for a minimum of two years or as per regulatory requirements.

6. Abbreviations

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7. Documents

  1. Annexure-1: Machine Operations Log
  2. Annexure-2: Machine Safety Check Log
  3. Annexure-3: Deviation Log
  4. Annexure-4: Equipment Maintenance Log
  5. Annexure-5: Equipment Shutdown Log

8. References

9. SOP Version

Version: 2.0

10. Approval Section

Prepared By Checked By Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Machine Operations Log

Batch Number Machine ID Operator Start Time End Time Operational Parameters
12345 HM-001 John Doe 10:00 AM 2:00 PM Speed: 120 RPM, Temp: 25°C

Annexure-2: Machine Safety Check Log

Machine ID Safety Feature Check Date Pass/Fail Comments
HM-001 Emergency Stop 21/01/2026 Pass All safety features functioning properly

Annexure-3: Deviation Log

Deviation Date Batch Number Deviation Description Corrective Action Taken Operator
21/01/2026 12345 Excessive temperature Adjusted temperature settings John Doe

Annexure-4: Equipment Maintenance Log

Equipment ID Maintenance Date Maintenance Activity Operator Comments
HM-001 21/01/2026 Lubrication Jane Smith Lubricated moving parts

Annexure-5: Equipment Shutdown Log

Machine ID Shutdown Date Reason Operator Comments
HM-001 21/01/2026 End of production John Doe No issues during shutdown

Revision History:

Revision Date Revision No. Revision Details Reason for Revision Approved By
01/03/2024 1.0 Initial Version New SOP Creation QA Head
01/03/2025 2.0 Format Revision and Updates Standardization of Document QA Head
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