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