Creams: SOP for Ensuring GMP Compliance in Machine Operations for Creams – V 2.0

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Creams: SOP for Ensuring GMP Compliance in Machine Operations for Creams – V 2.0

Standard Operating Procedure for Ensuring GMP Compliance in Machine Operations for Creams

Department Creams
SOP No. SOP/CRM/112/2025
Supersedes SOP/CRM/112/2022
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 outline the procedures to ensure that machine operations in the cream manufacturing process comply with Good Manufacturing Practices (GMP). This ensures product quality, safety, and regulatory compliance throughout production.

2. Scope

This SOP applies to all cream manufacturing machines, including filling machines, homogenizers, mixers, and packaging equipment. It covers the monitoring and control of machine operations to maintain GMP compliance during the manufacturing process.

3. Responsibilities

  • Production Team: Responsible for following the SOPs during machine operation and ensuring all equipment is used in compliance with GMP standards.
  • Maintenance Team: Ensures that machines are well-maintained and calibrated to meet GMP requirements, performing regular inspections and corrective actions when needed.
  • Quality Control (QC): Verifies that machine operations comply with GMP guidelines and ensures that product quality is consistent with regulatory standards.

4. Accountability

The Production Supervisor is accountable for ensuring that machine operations are conducted in accordance with GMP guidelines. The Maintenance Manager is responsible for the ongoing calibration and maintenance of equipment to maintain GMP compliance.

5. Procedure

5.1 Equipment Calibration and Maintenance

  1. Ensure that all machines used in the production process are calibrated and maintained according to the manufacturer’s guidelines and the internal maintenance schedule.
  2. Perform routine checks and preventive maintenance on machines to ensure they are in optimal working condition. Document all maintenance activities in the Equipment Maintenance Log (Annexure-1).
  3. Ensure that all machines are free from defects and meet the necessary performance standards before each production run.
  4. Ensure that the calibration of critical equipment (e.g., filling machines, homogenizers) is verified and recorded according to established procedures.
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5.2 Operating Procedures and Compliance

  1. Follow the operating procedures for each machine as outlined in their respective SOPs to ensure consistent and GMP-compliant operations during production.
  2. Ensure that all operators are trained on proper machine operation and understand GMP requirements, including hygiene practices and equipment handling.
  3. Ensure that all machines are operated in a clean environment and that product contact surfaces are sanitized according to the cleaning SOPs to prevent contamination.
  4. Monitor the machines during production to ensure they are functioning correctly and that the required product specifications are met.
  5. Ensure that all settings, such as speed, pressure, temperature, and volume, are checked regularly to ensure compliance with the recipe specifications and GMP standards.

5.3 Documentation and Record-Keeping

  1. Maintain accurate and up-to-date documentation of all machine operations, including calibration records, maintenance logs, and machine settings, in compliance with GMP standards.
  2. Ensure that all machine operators and maintenance staff document their activities, including any adjustments made to the machines, in the appropriate logbooks (e.g., Equipment Maintenance Log, Production Log, etc.).
  3. Ensure that all documentation is reviewed regularly by the Quality Assurance (QA) team to ensure GMP compliance and proper record-keeping practices.
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5.4 Monitoring and Audits

  1. Monitor machines during production to ensure that they continue to operate within the required parameters. Any deviations from the standard operating conditions should be immediately addressed and documented.
  2. Conduct regular internal audits to verify that machine operations are compliant with GMP standards. Audit findings should be documented and corrective actions should be taken as necessary.
  3. Ensure that any non-conformances found during audits or production are addressed promptly and that the corrective actions are implemented and documented.

5.5 Training and Competency

  1. Ensure that all personnel operating the machines are adequately trained on the specific machines they are using, including an understanding of GMP requirements for equipment operation.
  2. Provide ongoing training to operators and maintenance staff to keep them up to date on any changes in GMP regulations or machine operation procedures.
  3. Maintain records of all training activities, including dates, topics, and participants, in the Training Log (Annexure-2).

5.6 Handling Deviations

  1. If any machine malfunction or deviation from GMP occurs, stop the machine immediately and document the deviation in the Deviations Log (Annexure-3).
  2. Investigate the cause of the deviation and take corrective actions to bring the machine back into compliance. Ensure that all corrective actions are documented and implemented.
  3. Report any critical deviations to the Quality Assurance (QA) team for further investigation and corrective measures, ensuring compliance with GMP requirements.

5.7 Post-Operation Shutdown

  1. After completing a production run, ensure that the machines are properly shut down according to the manufacturer’s instructions. Perform any necessary cleaning or maintenance procedures as outlined in the Cleaning SOP for equipment.
  2. Ensure that the machines are stored properly when not in use to prevent any damage or contamination.
  3. Document the shutdown activities, including any issues encountered, in the Machine Shutdown Log (Annexure-4).
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6. Abbreviations

  • GMP: Good Manufacturing Practices
  • QC: Quality Control
  • QA: Quality Assurance
  • PPE: Personal Protective Equipment

7. Documents

  1. Annexure-1: Equipment Maintenance Log
  2. Annexure-2: Training Log
  3. Annexure-3: Deviations Log
  4. Annexure-4: Machine Shutdown Log

8. References

  • Good Manufacturing Practices (GMP) Guidelines – 21 CFR Part 211
  • International Conference on Harmonisation (ICH) Q7 – Good Manufacturing Practice for Active Pharmaceutical Ingredients
  • Machine Manufacturer’s Manual

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 Maintenance Log

Equipment ID Maintenance Date Maintenance Type Operator Comments
FM-001 21/01/2026 Routine Inspection and Lubrication John Doe No issues, machine performing optimally

Annexure-2: Training Log

Training Date Topic Trainer Participants Comments
15/01/2026 Machine Operation and GMP Compliance Jane Smith John Doe, Sarah Lee All participants were proficient after training

Annexure-3: Deviations Log

Deviation Date Batch Number Issue Identified Corrective Action Taken Operator
20/01/2026 12345 Underfilling in batch Recalibrated filling machine, replaced nozzle John Doe

Annexure-4: Machine Shutdown Log

Shutdown Date Equipment ID Reason for Shutdown Shutdown Duration Operator
21/01/2026 FM-001 End of Production Run 2 hours Sarah Lee

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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