Procedure for Transferring Ointments to Storage Tanks
| Department | Production/Quality Assurance (QA)/Engineering |
|---|---|
| SOP No. | SOP/Ointment/035 |
| Supersedes | V 1.0 |
| Page No. | Page X of Y |
| Issue Date | [Insert Issue Date] |
| Effective Date | [Insert Effective Date] |
| Review Date | [Insert Review Date] |
1. Purpose
The purpose of this Standard Operating Procedure (SOP) is to define a systematic method for transferring ointments from the processing vessel to storage tanks. Proper transfer ensures product integrity, prevents contamination, and maintains batch traceability.
2. Scope
This SOP applies to all personnel responsible for the transfer of ointments in the manufacturing process, including production operators, quality control (QC), and engineering staff.
3. Responsibilities
- Production Supervisor: Ensures adherence to transfer protocols.
- Machine Operator: Controls and monitors the transfer process.
- Quality Assurance (QA) Personnel: Verifies compliance with GMP and product quality.
- Engineering Technician: Maintains transfer equipment and ensures cleanliness.
4. Accountability
The Production and QA Managers are accountable for ensuring that the transfer of ointments is conducted as per GMP guidelines and documented correctly.
5. Procedure
5.1 Pre-Transfer Preparations
- Ensure that the storage tank and transfer lines are clean and sanitized.
- Verify that the ointment has completed the final mixing stage.
- Confirm that all equipment (pumps, pipes, hoses) is properly assembled and functional.
- Ensure the correct labeling of the storage tank with batch details.
5.2 Selection of Transfer Method
- Gravity Transfer: Used for small-scale operations
where height differential allows flow.
Vacuum Transfer: Used to minimize air contamination and ensure uniform product flow.
Pump Transfer: Used for high-viscosity ointments requiring controlled movement.
5.3 Initiating the Transfer
- Secure all connections between the processing vessel and the storage tank.
- Start the transfer process at a controlled rate to prevent aeration.
- Monitor the flow and ensure no leaks or blockages occur.
5.4 Monitoring During Transfer
- Check for uniform flow and prevent clogging in the transfer system.
- Ensure there is no excessive foaming or oxidation.
- Maintain the temperature if required for viscosity control.
5.5 Completion of Transfer
- Close all transfer valves to prevent accidental leakage.
- Disconnect transfer lines and flush them with an approved cleaning agent.
- Ensure proper tank labeling with batch details, date, and storage conditions.
5.6 Documentation and Approval
- Record all transfer details in the Ointment Transfer Log.
- QA must verify and approve the transferred batch before further processing.
- Label the batch as “Transferred and Ready for Storage.”
6. Abbreviations
- GMP – Good Manufacturing Practices
- QA – Quality Assurance
- QC – Quality Control
- BMR – Batch Manufacturing Record
7. Documents
- Ointment Transfer Log (Annexure-1)
- Storage Tank Verification Report (Annexure-2)
8. References
- WHO GMP Guidelines for Pharmaceutical Manufacturing
- 21 CFR Part 211 – Current Good Manufacturing Practices
- Equipment Manufacturer Guidelines
9. SOP Version
Version 2.0
10. Approval Section
| Prepared By | Checked By | Approved By | |
|---|---|---|---|
| Signature | |||
| Date | |||
| Name | |||
| Designation | |||
| Department |
11. Annexures
Annexure-1: Ointment Transfer Log
| Date | Batch Number | Transfer Method | Temperature (°C) | Transfer Time (Min) | Verified By |
|---|---|---|---|---|---|
| 01/02/2025 | SOP/Ointment/001 | Vacuum | 45°C | 20 | QA Officer |
| 02/02/2025 | SOP/Ointment/002 | Pump | 42°C | 25 | QA Officer |
Annexure-2: Storage Tank Verification Report
| Date | Batch Number | Tank ID | Cleaning Status | Temperature (°C) | Approved By |
|---|---|---|---|---|---|
| 01/02/2025 | SOP/Ointment/001 | ST-101 | Clean | 40°C | QA Head |
| 02/02/2025 | SOP/Ointment/002 | ST-102 | Clean | 42°C | QA Head |
12. Revision History:
| Revision Date | Revision No. | Details of Revision | Reason for Revision | Approved By |
|---|---|---|---|---|
| 01/01/2024 | 1.0 | Initial Version | New SOP | QA Head |
| 01/02/2025 | 2.0 | Updated SOP Format | Standardization of Document | QA Head |