Scope

This SOP applies to all line clearance activities prior to gel transfer in the Gel Manufacturing area of the facility.

3. Responsibilities

• Production Operator: Prepares area and equipment for clearance and notifies QA.
• QA Officer: Conducts line clearance, completes checklist, and authorizes transfer.
• Production Supervisor: Ensures implementation and documentation of procedure.

4. Accountability

Department Head – Gel Manufacturing

5. Procedure

5.1 Preparation for Line Clearance

1. Ensure completion of cleaning and drying of vessels, transfer lines, and holding tanks.
2. Remove all raw materials, printed materials, and product remnants of the previous batch.
3. Place “Line Clearance in Progress” signage at entry points.

5.2 QA Line Clearance Checks

1. Verify cleanliness of equipment, utensils, pipelines, and environment.
2. Check for absence of product residues, previous batch labels, and documents.
3. Ensure environmental conditions meet the specified limits for cleanliness and temperature.
4. Confirm calibration status of instruments and equipment.

5.3 Documentation

1. Record line clearance details in the Line Clearance Checklist (Annexure-1).
2. QA Officer and Production Supervisor to sign and date the clearance form.
3. Only after QA clearance can gel transfer begin.

5.4 Frequency

• Before every batch transfer activity.
• After cleaning or changeover of equipment or area.
• Post any maintenance or repair work within the gel transfer area.

6. Abbreviations

• QA: Quality Assurance
• SOP: Standard Operating Procedure
• cGMP: current Good Manufacturing Practices

7. Documents

1. Line Clearance Checklist – Annexure-1
2. Equipment Cleaning Log Book

8. References

• WHO TRS 986 – cGMP Guidelines
• FDA 21 CFR Part 211 – Subpart D: Equipment

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: Line Clearance Checklist

Check Point	Status (Yes/No)	Remarks
Area free from previous product residues
All raw and printed materials removed
Equipment cleaned and dried
No obsolete documents or labels present
Environmental parameters within limits
Calibration of instruments verified
QA Approval Given

Revision History

Revision Date	Revision No.	Change Description	Reason	Approved By
01/03/2022	1.0	Initial issue	New SOP	QA Head
09/06/2025	2.0	Updated checklist and formatting	cGMP Alignment	QA Head