are lubricated before each use. The QA Manager is responsible for verifying that lubrication is performed correctly, ensuring equipment runs smoothly during production.

5. Procedure

5.1 Pre-Lubrication Checks

1. Ensure that the filling machine is turned off and disconnected from the power supply before starting the lubrication procedure.
2. Verify that the area around the machine is clean and clear of any obstructions or potential contaminants.
3. Check that all necessary tools, lubricants, and safety equipment (e.g., gloves, goggles) are available before beginning the lubrication process.
4. Consult the manufacturer’s maintenance manual for specific lubrication points, recommended lubricants, and lubrication intervals.

5.2 Lubrication Procedure

1. Identify all mechanical parts that require lubrication. These typically include gears, conveyors, motors, and any moving parts that are subject to wear.
2. Apply the appropriate lubricant to each mechanical part. Use a clean cloth or brush for applying grease, and ensure that oil is applied with a spray or a dropper as necessary.
3. For gear mechanisms, apply grease directly to the gears, ensuring all moving parts are properly covered without over-lubricating.
4. For motors, apply lubricant to bearings, shafts, and other moving components, following the manufacturer’s instructions on the quantity of lubricant required.
5. Lubricate conveyor systems, ensuring that rollers, chains, and belts receive sufficient lubricant to prevent friction and wear.
6. Ensure that no excess lubricant is applied that may drip onto production surfaces or product containers. Wipe away any excess grease or oil to prevent contamination.

5.3 Post-Lubrication Checks

1. Inspect all lubricated parts to ensure that the lubricant has been applied correctly and is evenly distributed across all moving components.
2. Check for any leakage of oil or grease, especially near seals and joints. If there is any leakage, apply additional lubricant or address any seal issues before operation.
3. Ensure that no lubricant has come into contact with product contact surfaces or containers. If this occurs, clean the affected areas immediately.

5.4 Equipment Test

1. After lubrication, perform a test run of the filling machine without any product to ensure that the machine is operating smoothly. Listen for any unusual sounds such as squeaking or grinding that may indicate insufficient lubrication.
2. Monitor the operation of the machine during the test run to check for any abnormal movements, excessive vibrations, or overheating.
3. If any issues are identified, stop the machine immediately, adjust the lubrication, and repeat the test until the machine is functioning correctly.

5.5 Maintenance and Cleaning

1. After the lubrication process, clean the surrounding area of any spilled lubricant, ensuring no contamination occurs in the production area.
2. Inspect the lubrication system periodically for signs of wear or malfunction, and replace any damaged components as necessary.
3. Record all lubrication activities, including the type of lubricant used, parts lubricated, and any issues encountered, in the Equipment Maintenance Log (Annexure-1).

5.6 Documentation

1. Document all lubrication activities in the Equipment Maintenance Log (Annexure-1), including the date, parts lubricated, and any issues identified during the lubrication process.
2. Record the results of the test run and any adjustments made in the Equipment Test Run Log (Annexure-2).

5.7 Final Approval

1. The QA team must review the lubrication records and confirm that the equipment is ready for operation before the next production run. If any discrepancies are noted, the batch should be reviewed, and corrective actions should be taken before proceeding to production.

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: Equipment Test Run 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
• Manufacturer’s Guidelines for High-Shear Mixers and Filling Equipment

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	Lubrication, inspection	John Doe	Successfully completed

Annexure-2: Equipment Test Run Log

Equipment ID	Test Date	Test Performed	Operator	Results
FM-001	21/01/2026	Test run with water	Jane Smith	Successful, no issues detected

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