and monitors qualification protocol execution.

Quality Assurance: Reviews qualification data and approves results before line usage.

4. Accountability

Head – Manufacturing is accountable for ensuring that all transfer lines and hoses are qualified and maintained according to regulatory and in-house quality standards.

5. Procedure

5.1 Initiation

1. Identify new transfer lines or hoses requiring qualification.
2. Assign a unique Equipment ID and label the item.
3. Prepare and approve a qualification protocol including IQ, OQ, and PQ elements.

5.2 Installation Qualification (IQ)

1. Verify construction material compatibility with the gel formulation (e.g., silicone, PTFE).
2. Inspect physical condition, connectors, and clamps for mechanical integrity.
3. Check for cleanability and drainability features.

5.3 Operational Qualification (OQ)

1. Perform pressure leak test at defined operational pressure using purified water or inert gas.
2. Check flow rate under simulated manufacturing conditions.
3. Ensure connectors function properly with no visible leakage or misalignment.

5.4 Performance Qualification (PQ)

1. Run media trials (e.g., gel placebo) through the transfer line under normal operating conditions.
2. Assess hold-up volume, dead leg presence, and cleaning efficiency post-use.
3. Conduct microbial swab testing after cleaning to verify cleanliness.

5.5 Documentation and Approval

1. Compile IQ/OQ/PQ reports and attach test data, results, and deviations (if any).
2. QA to review and approve the qualification summary report.
3. Enter qualification details into the Equipment Qualification Register.

5.6 Requalification

1. Perform requalification every 3 years or earlier in case of damage or design change.
2. Document requalification in the same format with revision tracking.

6. Abbreviations

• IQ: Installation Qualification
• OQ: Operational Qualification
• PQ: Performance Qualification
• QA: Quality Assurance
• SOP: Standard Operating Procedure

7. Documents

1. Transfer Line Qualification Protocol – Annexure-1
2. Leak Test Report Format – Annexure-2
3. Microbial Swab Report – Annexure-3
4. Qualification Summary Report – Annexure-4

8. References

• ISPE Baseline Guide – Volume 5: Commissioning and Qualification
• WHO TRS 961 Annex 6: GMP for Pharmaceutical Products
• FDA Guidance for Industry – Process 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: Transfer Line Qualification Protocol

Equipment ID
Material of Construction
Line Length
Installation Date
IQ Completed	Yes/No
OQ Completed	Yes/No
PQ Completed	Yes/No
Remarks

Annexure-2: Leak Test Report Format

Date	Test Pressure	Duration	Result	Tested By

Annexure-3: Microbial Swab Report

Sample Location	Date	Result (cfu/25 cm²)	Accepted Limit	Tested By
			Not more than 10

Annexure-4: Qualification Summary Report

Equipment ID	Summary of Results	Conclusion	Approved By
		Qualified / Not Qualified

Revision History

Revision Date	Revision No.	Change Description	Reason	Approved By
18/06/2022	1.0	Initial SOP Release	New Equipment Introduction	QA Head
09/06/2025	2.0	Added PQ and microbial testing sections	Annual SOP Review	QA Head