Manufacturing Department that are to be transferred for primary packaging on automated or semi-automated filling lines.

3. Responsibilities

• Production Personnel: Responsible for carrying out the gel transfer operation as per protocol.
• Quality Assurance: To ensure adherence to SOP, monitor transfer process, and verify cleanliness.
• Engineering Department: To maintain and calibrate transfer equipment and hose assemblies.

4. Accountability

The Head – Manufacturing is accountable for the proper execution and documentation of gel transfers to the filling line.

5. Procedure

5.1 Pre-Transfer Preparations

1. Verify that the gel batch is approved for filling and labeled with status tag “Ready for Filling.”
2. Ensure that the receiving hopper on the filling line is clean and appropriately labeled.
3. Confirm the availability of sanitized and dedicated transfer hoses, clamps, and nozzles.
4. Review the Batch Manufacturing Record (BMR) for any specific transfer instructions.

5.2 Transfer Method Selection

1. For closed systems, connect the transfer hose from the bulk gel storage tank to the filling hopper.
2. Use a positive displacement pump or gravity-based transfer depending on batch size and equipment compatibility.
3. For open transfer systems, use sanitized containers with lids and transfer using peristaltic pumps or manual pouring under laminar airflow (LAF) unit.

5.3 Execution of Transfer

1. Begin the transfer at low flow rate to avoid air entrapment and splashing.
2. Monitor the filling hopper for overfill or underfill; maintain consistent flow rate.
3. Gently stir the hopper contents periodically if required to prevent settling.
4. Record the start and end time of the transfer operation in the Gel Transfer Log – Annexure-1.

5.4 Post-Transfer Checks

1. Ensure complete transfer of material and visually inspect for any remaining residues in the transfer line.
2. Detach and immediately clean transfer hoses and fittings as per the Cleaning SOP.
3. Update status of the bulk tank to “Transferred” and apply new tag to indicate completion.

5.5 Precautions

• Avoid use of excessive force during pump transfer to prevent shear degradation.
• Ensure line clearance from previous product prior to setup.
• Do not allow open contact between gel and external environment beyond validated hold time.

6. Abbreviations

• BMR: Batch Manufacturing Record
• SOP: Standard Operating Procedure
• LAF: Laminar Airflow
• QA: Quality Assurance

7. Documents

1. Gel Transfer Log – Annexure-1
2. Equipment Line Clearance Form – Annexure-2
3. Batch Manufacturing Record (BMR)

8. References

• Schedule M – Transfer of Bulk Materials Guidelines
• WHO GMP Annex on Pharmaceutical Manufacturing

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: Gel Transfer Log

Record includes date, batch number, quantity transferred, equipment ID, operator initials, and QA verification.

Annexure-2: Equipment Line Clearance Form

Checklist to confirm cleanliness and readiness of hoses, vessels, and pump systems prior to use.

Revision History:

Revision Date	Revision No.	Details	Reason	Approved By
01/05/2022	1.0	Initial procedure for gel transfer	Process Control	QA Head
02/06/2025	2.0	Updated transfer validation steps and equipment log	GMP compliance	QA Head