The QA Manager is responsible for reviewing the validation results and ensuring compliance with product specifications and regulatory standards.

5. Procedure

5.1 Pre-Validation Setup

1. Ensure that the cream-filling machine is properly calibrated before starting the validation process. Check that the machine settings (speed, pressure, volume) are correctly configured according to the batch requirements.
2. Verify that the appropriate containers are available for filling and are free from defects.
3. Ensure that the cream to be filled is properly prepared, mixed, and at the correct temperature for filling.
4. Ensure that the necessary tools for volume measurement, such as a balance or graduated cylinder, are available and calibrated.

5.2 Performing Volume Validation

1. Start the cream-filling machine and begin filling the containers at the designated speed.
2. For each batch, select a random sample of filled containers and measure the volume of cream in each container using a calibrated balance or graduated cylinder.
3. Record the volume for each sample and compare it with the specified filling volume for the product.
4. If the measured volume deviates from the specified volume by more than the allowed tolerance, stop the machine and adjust the filling parameters as necessary (e.g., nozzle position, filling speed, pressure).
5. Repeat the volume measurement for additional containers to ensure consistency across the entire batch. If any further deviations occur, stop the machine and recalibrate it.

5.3 Monitoring During Production

1. Continuously monitor the filling process during production. If any issues with filling volume arise, take immediate corrective action, such as adjusting the filling machine settings or halting production to troubleshoot the issue.
2. Regularly perform random sampling throughout the production run to verify that the filling volume remains consistent and within the specified range.
3. Record any corrective actions taken, including adjustments to the machine settings, in the Production Log (Annexure-1).

5.4 Post-Validation Checks

1. Once the filling process is complete, inspect a sample of filled containers for consistency in filling volume.
2. Perform a final check of the filled containers to ensure that there are no overfills or underfills. If any containers are found outside the specified volume range, recheck the machine settings and adjust as necessary.
3. Document the results of the volume validation, including the number of containers checked, the measured volumes, and any corrective actions taken, in the Batch Production Record (Annexure-2).

5.5 Equipment Calibration and Maintenance

1. Ensure that the filling machine is calibrated before the validation process begins and after any adjustments are made during production.
2. Record any calibration activities and adjustments made to the equipment in the Equipment Calibration Log (Annexure-3).
3. Perform routine maintenance on the filling machine to ensure its proper function, especially after volume validation checks or adjustments.

5.6 Documentation

1. Record all volume validation results, including sample volumes and any deviations observed, in the Batch Production Record (Annexure-2).
2. Document any corrective actions, such as adjustments made to the filling machine or recalibration, in the Production Log (Annexure-1).
3. Record the results of the equipment calibration and maintenance activities in the Equipment Calibration Log (Annexure-3).

5.7 Final Approval

1. The QA team must review the volume validation results, including the Batch Production Record and any corrective actions, to ensure that the filling process meets the required specifications before approval for the next production phase.
2. If any deviations are found during validation, the batch should be reviewed, and corrective actions should be taken to ensure compliance before proceeding with production.

6. Abbreviations

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

7. Documents

1. Annexure-1: Production Log
2. Annexure-2: Batch Production Record
3. Annexure-3: Equipment Calibration 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 Filling and Packaging 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: Production Log

Batch Number	Validation Date	Number of Containers Checked	Operator	Comments
12345	21/01/2026	50	John Doe	No discrepancies found

Annexure-2: Batch Production Record

Batch Number	Filling Volume	Measured Volume	Operator	Comments
12345	500 mL	499 mL	Jane Smith	Volume within acceptable tolerance

Annexure-3: Equipment Calibration Log

Equipment ID	Calibration Date	Calibration Type	Operator	Comments
FM-001	21/01/2026	Filling Volume Calibration	John Doe	Calibration successful, all parameters within limits

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