or repair needs.

QA Executive: Verifies compliance and ensures logbook entries are complete.

4. Accountability

The Head – Manufacturing is accountable for ensuring proper training, operation, maintenance, and documentation related to gel transfer pump operations.

5. Procedure

5.1 Pre-Operational Checks

1. Ensure that the pump is clean and labeled “CLEANED.”
2. Verify pump calibration and maintenance status from the equipment logbook.
3. Check that all pump parts, hoses, and fittings are properly assembled and leak-free.
4. Confirm that the electrical connections are secure and the area is free from hazards.

5.2 Setup

1. Position the pump securely between the source and receiving vessels.
2. Connect the inlet hose to the outlet valve of the manufacturing vessel.
3. Connect the outlet hose to the receiving vessel (e.g., storage container or filling hopper).
4. Ensure clamps and fittings are tight to avoid contamination or product loss.

5.3 Operation

1. Switch ON the pump using the main control switch.
2. Start at the lowest speed setting and gradually increase based on product viscosity and flow rate required.
3. Monitor the transfer process continuously to ensure uninterrupted flow and prevent overflow or underfill.
4. Use flow meters or visual indicators, if available, to regulate flow and avoid air entrapment.

5.4 Post-Operational Activities

1. Turn OFF the pump once the transfer is complete.
2. Disconnect hoses and empty remaining product using reverse operation if required.
3. Clean the pump and associated hoses as per the cleaning SOP.
4. Label equipment appropriately and return to designated area.

5.5 Documentation

1. Record equipment usage, cleaning status, and batch transfer details in the Equipment Usage Logbook – Annexure-1.
2. Note any abnormalities or deviations encountered during operation and report to QA and Engineering.

5.6 Troubleshooting Guidelines

• Issue: Pump not starting – Check: Power supply, fuse, or switch.
• Issue: Flow rate too low – Check: Viscosity of gel, hose blockage, or incorrect speed.
• Issue: Leakage – Check: Loose fittings or damaged seals.

6. Abbreviations

• SOP: Standard Operating Procedure
• QA: Quality Assurance
• GMP: Good Manufacturing Practice
• RPM: Revolutions Per Minute

7. Documents

1. Equipment Usage Logbook – Annexure-1
2. Cleaning SOP for Transfer Pump
3. Maintenance Record Sheet

8. References

• GMP Guidelines – Schedule M
• EU GMP Annex 15: Qualification and Validation

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: Equipment Usage Logbook Format

Date	Batch No.	Start Time	End Time	Operator Name	Remarks

Revision History

Revision Date	Revision No.	Change Description	Reason	Approved By
25/03/2022	1.0	Initial issue	New Equipment Implementation	QA Head
09/06/2025	2.0	Updated flow control section and annexures	Routine Review	QA Head