Standard Operating Procedure for Operating Automatic Labeling Machines
| Department | Creams |
|---|---|
| SOP No. | SOP/CRM/089/2025 |
| Supersedes | SOP/CRM/089/2022 |
| 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 operating automatic labeling machines for cream packaging. The objective is to ensure that all cream containers are accurately labeled with correct product information, batch numbers, and expiration dates.
2. Scope
This SOP applies to the operation of all automatic labeling machines in the Creams Department used for labeling cream containers. It includes setup, operation, monitoring, and maintenance of the labeling machines.
3. Responsibilities
- Production Team: Responsible for setting up, operating, and monitoring the automatic labeling machines to ensure accurate labeling of all containers.
- Quality Control (QC): Ensures that the labels on the containers meet the required specifications, including the correct batch numbers and expiration dates.
- Maintenance Team: Ensures that the labeling machines are properly maintained, calibrated, and cleaned regularly to avoid malfunctions during production.
4. Accountability
The Head of Production is accountable for ensuring that labeling machines are operated correctly and that the labeling process meets all quality standards. The QA Manager is responsible for verifying that all products are labeled with correct information before shipment.
5. Procedure
5.1 Pre-Operation Setup
- Ensure that the labeling machine is clean and free of contaminants. Perform a cleaning procedure as per the cleaning SOP.
- Verify that the correct labels are available for the batch being produced, with accurate product information, batch numbers, and expiration dates.
- Check that the labeling machine components, including label reels, sensors, and conveyors, are properly assembled and in good working condition.
- Set up the labeling machine to the correct speed and labeling pressure as per the batch requirements. Adjust the label alignment and positioning settings according to the product specifications.
- Ensure that the cream containers are properly positioned on the conveyor system and ready for labeling.
5.2 Operating the Labeling Machine
- Start the automatic labeling machine, ensuring that it is running at the set speed and pressure.
- Monitor the labeling process to ensure that labels are applied accurately, without wrinkles, misalignment, or incorrect positioning.
- Check that the correct number of labels are applied to each container, including the correct batch number and expiration date.
- If the labels are not aligned correctly or there are any issues such as under-labeling or over-labeling, stop the machine and adjust the settings accordingly.
- Verify that the labeling machine is running smoothly, with no jams or misfeeds. If any containers are mis-labeled or do not receive labels, stop the machine and identify the cause of the issue.
5.3 Monitoring During Operation
- Continuously monitor the machine for any issues, such as label misalignment, label tearing, or machine malfunctions.
- Inspect labeled containers to ensure labels are applied consistently and in the correct position. Perform regular checks on the labels for accuracy.
- In case of any issues, stop the machine, identify the problem, and make the necessary adjustments. Record any issues or downtime in the Production Log (Annexure-1).
5.4 Post-Operation Checks
- Once the labeling process is complete, inspect a sample of labeled containers to ensure they meet the required specifications for label placement, accuracy, and legibility.
- Check that the labels are intact, with no peeling, smudging, or misprints. Ensure that all labeled containers have the correct batch numbers, expiration dates, and product information.
- Record the number of containers labeled, and document any issues encountered during the labeling process in the Batch Production Record (Annexure-2).
5.5 Maintenance and Cleaning
- After the labeling process is complete, clean the labeling machine to remove any residue or debris that could affect the next production run.
- Perform routine maintenance on the labeling machine, including inspection of label reels, sensors, and other moving parts to ensure they are in good working condition.
- Document all maintenance activities in the Equipment Maintenance Log (Annexure-3).
5.6 Documentation
- Record all relevant information in the Batch Production Record (Annexure-2), including the number of containers labeled, any discrepancies in labeling, and the performance of the labeling machine.
- Document any maintenance or issues encountered during the labeling process in the Equipment Maintenance Log (Annexure-3) and the Production Log (Annexure-1).
5.7 Final Approval
- The QA team must review the final product, including the labeled containers and batch production records, to verify that all products are correctly labeled and meet quality standards before approval for further processing or shipment.
- If any deviations from the set parameters or product quality are identified, the batch should be reviewed, and corrective actions should be taken before proceeding to the next phase.
6. Abbreviations
- GMP: Good Manufacturing Practices
- QC: Quality Control
- QA: Quality Assurance
- PPE: Personal Protective Equipment
7. Documents
- Annexure-1: Production Log
- Annexure-2: Batch Production Record
- Annexure-3: Equipment Maintenance 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
- 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: Production Log
| Batch Number | Production Date | Number of Containers Labeled | Operator | Comments |
|---|---|---|---|---|
| 12345 | 21/01/2026 | 5000 | Jane Smith | No issues encountered |
Annexure-2: Batch Production Record
| Batch Number | Filling Volume | Labeling Details | Operator | Comments |
|---|---|---|---|---|
| 12345 | 5000 L | Correct label placement | John Doe | Successfully completed labeling |
Annexure-3: Equipment Maintenance Log
| Equipment ID | Maintenance Date | Maintenance Type | Operator | Comments |
|---|---|---|---|---|
| LM-001 | 21/01/2026 | Inspection, calibration | Jane Smith | Successfully calibrated |
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 |