Standard Operating Procedure for Routine Calibration of Tube Filling Machine in Gel Manufacturing
| Department | Gel Manufacturing |
|---|---|
| SOP No. | SOP/GM/160/2025 |
| Supersedes | SOP/GM/160/2022 |
| Page No. | Page 1 of 11 |
| Issue Date | 09/06/2025 |
| Effective Date | 11/06/2025 |
| Review Date | 09/06/2027 |
1. Purpose
To define the procedure for routine calibration of the tube filling machine used in gel manufacturing to ensure consistent volumetric accuracy, reduce wastage, and comply with GMP guidelines.
2. Scope
This SOP applies to the periodic calibration of all tube filling machines installed in the gel manufacturing section of the formulation plant.
3. Responsibilities
- Calibration Technician: Performs the calibration activity as per schedule.
- Production Supervisor: Coordinates machine availability for calibration.
- QA Executive: Verifies calibration results and reviews documentation.
4. Accountability
Head – Engineering is accountable
for timely and compliant execution of the calibration program. QA is responsible for final approval and documentation compliance.
5. Procedure
5.1 Preparation
- Review the Calibration Schedule and ensure the activity is due.
- Inform the production team and obtain approval for machine downtime.
- Gather calibrated weights, containers, and reference standards required for the process.
- Ensure the machine is cleaned and free from residual product.
5.2 Calibration of Filling Volume
- Switch on the machine and allow it to reach normal operating condition.
- Select a standard fill volume (e.g., 30 g or 50 g depending on batch requirement).
- Weigh 10 filled tubes individually using a calibrated balance.
- Record each weight and calculate the average and standard deviation.
- Compare the results with the target fill weight and tolerance limits (±2%).
- If results fall within specification, consider calibration successful.
- If out-of-specification, adjust machine settings and repeat the test.
5.3 Recording and Review
- Record observations in the Calibration Worksheet – Annexure-1.
- Ensure all data is legibly recorded with date, time, initials, and instrument ID.
- QA Executive reviews the worksheet and signs off on accuracy and completeness.
5.4 Handling of Deviations
- If repeated calibration attempts fail, raise a deviation report.
- Quarantine the equipment until resolution of issue and re-calibration.
- Inform QA and Engineering Head for further action and root cause analysis.
6. Abbreviations
- SOP: Standard Operating Procedure
- QA: Quality Assurance
- GMP: Good Manufacturing Practice
- ID: Identification
7. Documents
- Calibration Schedule
- Calibration Worksheet – Annexure-1
- Deviation Report Form – Annexure-2
8. References
- Schedule M: Equipment Calibration Guidelines
- WHO TRS 937 Annex 4: Calibration of Equipment
9. SOP Version
Version: 2.0
10. Approval Section
| Prepared By | Checked By | Approved By | |
|---|---|---|---|
| Signature | |||
| Date | |||
| Name | |||
| Designation | Jr. Production Chemist | QA Executive | Head – Manufacturing |
| Department | Gel Manufacturing | Quality Assurance | Manufacturing |
11. Annexures
Annexure-1: Calibration Worksheet Format
| Sample No. | Target Weight (g) | Observed Weight (g) | Deviation (%) | Remarks |
|---|---|---|---|---|
| 1 | 50.00 | |||
| 2 | 50.00 | |||
| … | … |
Annexure-2: Deviation Report Form
| Deviation No. | |
|---|---|
| Date | |
| Description | |
| Root Cause | |
| Corrective Action | |
| Preventive Action | |
| Reviewed By |
Revision History
| Revision Date | Revision No. | Change Description | Reason | Approved By |
|---|---|---|---|---|
| 15/04/2022 | 1.0 | Initial issue | Standardization | QA Head |
| 09/06/2025 | 2.0 | Updated calibration frequency and annexures | Annual review | QA Head |