Standard Operating Procedure for Start-Up Checks on Manufacturing Equipment

Department	Creams
SOP No.	SOP/CRM/061/2025
Supersedes	SOP/CRM/061/2022
Page No.	Page 1 of 6
Issue Date	22/12/2025
Effective Date	27/12/2025
Review Date	22/12/2026

1. Purpose

The purpose of this Standard Operating Procedure (SOP) is to define the steps required for performing start-up checks on manufacturing equipment used in the production of creams. These checks are essential to ensure that all equipment is functioning properly and safely before production begins, thereby reducing the risk of equipment failure, ensuring product quality, and maintaining compliance with Good Manufacturing Practices (GMP).

2. Scope

This SOP applies to all manufacturing equipment used in the Creams Department, including mixers, homogenizers, filling machines, and any other equipment involved in the cream manufacturing process. It covers the procedure for verifying equipment readiness and safety before the start of production.

3. Responsibilities

• Production Team: Responsible for performing the start-up checks according to this SOP and ensuring that all equipment is fully operational and ready for use before initiating production.
• Quality Control (QC): Responsible for verifying that the equipment checks are completed accurately and that the equipment is free from any defects or contamination.
• Maintenance Team: Responsible for ensuring that the equipment is well-maintained and that any necessary repairs or adjustments are completed before the start of production.
• Quality Assurance (QA): Responsible for reviewing the completed start-up checklists and ensuring compliance with this SOP before approving the equipment for production use.

4. Accountability

The Head of Creams Manufacturing is responsible for ensuring that start-up checks are completed properly and in a timely manner. The QA Manager is accountable for reviewing and approving the results of the start-up checks before production begins.

5. Procedure

5.1 Pre-Start-Up Preparation

1. Ensure that all necessary equipment and tools required for the start-up checks are available and in good working condition. This includes checklists, inspection tools, calibration equipment, and any personal protective equipment (PPE) required for the task.
2. Review the equipment maintenance logs to ensure that all scheduled maintenance tasks have been completed, and that the equipment is in optimal condition.
3. Ensure that the area around the equipment is clean, free of obstructions, and adequately prepared for start-up.

5.2 Visual Inspection of Equipment

1. Perform a visual inspection of all equipment to check for any visible signs of damage, wear, or contamination. This includes checking:
   • Hoses, pumps, and valves for leaks or cracks
   • Mixing and homogenizing equipment for proper alignment and no signs of damage
   • Filling machines for any blockages or malfunctions
   • All safety guards and emergency stops to ensure they are intact and functional
2. If any equipment is found to be damaged or not functioning properly, report it to the Maintenance Team for immediate repairs. Do not proceed with production until the issue is resolved.

5.3 Equipment Calibration and Settings

1. Verify that all equipment is properly calibrated before use. This includes:
   • Checking temperature settings for mixers and homogenizers
   • Verifying filling volumes for filling machines
   • Ensuring that flow rates for pumps and mixing speeds are set according to the standard operating conditions for the batch being processed
2. If the equipment requires calibration, ensure that the calibration is performed according to the equipment manual and that calibration records are documented.

5.4 Functional Testing

1. Perform a functional test on each piece of equipment to ensure it operates correctly. This includes:
   • Running the equipment without material to ensure proper functionality
   • Testing mixing, homogenizing, and pumping actions
   • Checking filling machines to ensure the correct fill levels are achieved
2. During testing, observe for any irregular sounds, vibrations, or malfunctions. Any issues identified should be reported to the Maintenance Team for corrective actions.

5.5 Safety Checks

1. Conduct a safety check to ensure that all safety devices (e.g., emergency stops, safety interlocks) are functioning properly and have not been bypassed or tampered with.
2. Verify that all personal protective equipment (PPE), such as gloves, safety goggles, and hearing protection, is available and in good condition.
3. Ensure that all emergency exits and safety equipment, such as fire extinguishers, are accessible and operational.

5.6 Documentation of Start-Up Checks

1. Complete the Start-Up Checklist (Annexure-1) for each piece of equipment, documenting the results of the inspection, calibration, and functional tests.
2. If any deviations or issues are found during the start-up checks, document them in the Deviation Report Form (Annexure-2) and report them to the appropriate team (e.g., Maintenance, QA).
3. Ensure that all start-up checklists are signed and dated by the operator performing the checks and reviewed by the QA team.

5.7 Final Approval

1. The QA team must review the completed start-up checklists, ensuring that all required checks have been performed and that the equipment is safe and ready for use.
2. Once the QA team approves the equipment, the production team can begin the manufacturing process.

5.8 Ongoing Monitoring

1. Monitor the performance of the equipment throughout the production process to ensure it continues to function as expected. If any issues arise during production, stop the process and perform troubleshooting and corrective actions as necessary.

6. Abbreviations

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

7. Documents

1. Start-Up Checklist (Annexure-1)
2. Deviation Report Form (Annexure-2)

8. References

• Good Manufacturing Practices (GMP) Guidelines – 21 CFR Part 211
• International Conference on Harmonisation (ICH) Q7 – Good Manufacturing Practice for Active Pharmaceutical Ingredients
• FDA Guidelines for Cosmetics Manufacturing

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Start-Up Checklist

Equipment	Inspection Item	Result	Initials	Comments
Mixing Tank	Visual Inspection	Pass	J.D.	No issues

Annexure-2: Deviation Report Form

Deviation Description	Time	Batch Number	Operator	Immediate Action
Equipment malfunction	08:00 AM	12345	John Doe	Notified maintenance

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