are taken when necessary to ensure compliance with product specifications.

4. Accountability

The Production Manager is accountable for ensuring that tube-filling volumes are checked regularly during production and that any issues are promptly addressed. The QC Manager is responsible for ensuring the accuracy of the volume checks and documentation. The Laboratory Supervisor is responsible for ensuring that the tubes meet the required specifications before they are released for packaging.

5. Procedure

5.1 Pre-Production Setup

1. Ensure that the tube-filling machine is calibrated and set to the correct volume as per the product specifications. The machine should be checked for proper operation before beginning the production run.
2. Review the Batch Manufacturing Record (BMR) to verify the required fill volume for the batch and ensure that all necessary equipment and materials are ready for use.
3. Verify that all required documentation, such as filling logs and quality control checklists, are available and ready for use.

5.2 Tube-Filling Process and Volume Checking

1. During the tube-filling process, verify that the filling machine is dispensing the correct volume of cream into each tube. This can be done manually or with an automated volume-checking system.
2. Take random samples of filled tubes at specified intervals during the production run (e.g., every 100th tube, or as per the BMR instructions) and check the volume using a calibrated measuring device, such as a graduated cylinder or automated volume measurement system.
3. Record the volume for each sample in the Tube-Filling Volume Log (Annexure-1). Ensure that each entry includes the tube number, volume measurement, operator name, and time of measurement.
4. If the tube volume is found to be outside the acceptable tolerance range (as specified in the BMR), stop the filling process immediately and investigate the cause of the discrepancy.
5. Document any deviations from the set volume in the Deviation Report (Annexure-2) and initiate corrective actions, such as recalibration of the filling machine or adjustment of the fill volume settings.

5.3 Handling Deviations

1. If any filled tube exceeds or falls short of the acceptable volume limits, stop the production process to investigate the cause of the deviation.
2. Check the filling machine for potential issues, such as blockages, air pockets, or misalignment, which could cause inconsistent filling volumes.
3. Adjust the machine settings or perform any necessary maintenance to bring the filling volume back within the acceptable range. After adjustments, resume the production process, but continue to monitor the filling volumes closely.
4. Record all corrective actions taken in the Deviation Report (Annexure-2) and ensure that the report is reviewed by the QA team before resuming production.

5.4 Post-Production Activities

1. Once the batch is complete, review the Tube-Filling Volume Log (Annexure-1) to ensure that all required checks were completed and that no deviations were left unaddressed.
2. If the batch is verified to meet the required tube-filling volumes, approve the batch for the next stage in production (e.g., packaging and sealing).
3. Ensure that all filled tubes are properly sealed and labeled before moving to the packaging stage. The batch must be approved by the QA team before packaging begins.

5.5 Documentation and Record-Keeping

1. Record all tube-filling volume checks in the Tube-Filling Volume Log (Annexure-1), ensuring that each entry includes the batch number, time, operator name, and the volume measurement.
2. Ensure that any deviations and corrective actions are documented in the Deviation Report (Annexure-2) and that the report is signed off by the operator, supervisor, and QA personnel.
3. Ensure that all records are reviewed by the QC team for completeness and accuracy before filing. All records should be maintained for at least two years or as required by regulatory guidelines for traceability and auditing purposes.

6. Abbreviations

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

7. Documents

1. Annexure-1: Tube-Filling Volume Log
2. Annexure-2: Deviation Report

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 Guidance for Industry: Volume Control in Pharmaceutical 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: Tube-Filling Volume Log

Batch Number	Time	Tube Number	Filling Volume (ml)	Operator	Remarks
12345	09:00 AM	1	50 ml	John Doe	Within specification
12345	09:30 AM	2	51 ml	Jane Smith	Within specification
12345	10:00 AM	3	52 ml	Michael Lee	Within specification
12345	10:30 AM	4	48 ml	John Doe	Out of specification, corrective action taken

Annexure-2: Deviation Report

Batch Number	Deviation Description	Corrective Action	Resolved By
12345	Tube filling volume below specification	Re-calibrated filling machine, adjusted settings	Michael 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