Standard Operating Procedure for Calibration of Storage Vessels in API Manufacturing
| Department | API Manufacturing |
|---|---|
| SOP No. | SOP/API/052/2025 |
| Supersedes | SOP/API/052/2022 |
| Page No. | Page 1 of 10 |
| Issue Date | 13/04/2025 |
| Effective Date | 15/04/2025 |
| Review Date | 13/04/2026 |
1. Purpose
To establish a standard method for the calibration of storage vessels used in API manufacturing, ensuring accurate measurement of liquid volumes and maintaining GMP-compliant process control.
2. Scope
This SOP applies to all vertical and horizontal storage vessels used for holding solvents, intermediates, and reagents in the API manufacturing plant.
3. Responsibilities
- Engineering Department: Perform calibration as per defined procedure.
- Production
Department: Prepare the vessel and support calibration activities.
QA Department: Review calibration data and approve vessel for use.
4. Accountability
The Engineering Head is accountable for the execution of calibration. QA Head is accountable for final approval and regulatory compliance.
5. Procedure
5.1 Preparation for Calibration
- Ensure the vessel is:
- Empty and cleaned
- Free from previous product or solvent residue
- Fitted with a level gauge or dipstick
- Verify availability of:
- Calibrated flow meter / graduated containers
- Calibration tag and checklist
- PPE for personnel
5.2 Calibration Procedure
- Fill the vessel with known volumes of water (or appropriate calibration fluid) in 50 L or 100 L increments.
- At each level, record:
- Volume added
- Dipstick or sight glass reading
- Continue until the vessel reaches its maximum marked capacity.
- Plot a calibration chart (Volume vs. Level) for accurate volume referencing.
5.3 Documentation and Labeling
- Enter all data in the “Storage Vessel Calibration Record” (Annexure-1).
- Affix calibration chart near the vessel or in the SCADA system if automated.
- Label the vessel with:
- Calibration Date
- Next Due Date
- Calibrated By
5.4 Recalibration and Frequency
- Calibrate vessels:
- Initially during installation
- Annually thereafter
- After vessel repair or modification
- Track due dates in the “Calibration Schedule Register” (Annexure-2).
6. Abbreviations
- SOP: Standard Operating Procedure
- PPE: Personal Protective Equipment
- QA: Quality Assurance
- SCADA: Supervisory Control and Data Acquisition
7. Documents
- Storage Vessel Calibration Record (Annexure-1)
- Calibration Schedule Register (Annexure-2)
8. References
- ICH Q7 – Good Manufacturing Practice for Active Pharmaceutical Ingredients
- 21 CFR Part 211 – Equipment Calibration Requirements
- Company Engineering Manual
9. SOP Version
Version: 2.0
10. Approval Section
| Prepared By | Checked By | Approved By | |
|---|---|---|---|
| Signature | |||
| Date | |||
| Name | |||
| Designation | |||
| Department |
11. Annexures
Annexure-1: Storage Vessel Calibration Record
| Vessel ID | Volume Added (L) | Level Reading (cm) | Observed By | Date |
|---|---|---|---|---|
| SV-01 | 100 | 12.5 | 13/04/2025 |
Annexure-2: Calibration Schedule Register
| Vessel ID | Last Calibration Date | Next Due Date | Status | Remarks |
|---|---|---|---|---|
| SV-01 | 13/04/2025 | 13/04/2026 | Calibrated | OK |
Revision History:
| Revision Date | Revision No. | Details | Reason | Approved By |
|---|---|---|---|---|
| 01/01/2022 | 1.0 | Initial SOP Release | New Equipment Commissioning | QA Head |
| 13/04/2025 | 2.0 | Included SCADA and Frequency Guidelines | Audit Feedback | QA Head |