starts.

Production Supervisor: Oversees the line clearance process, ensures adherence to procedures, and signs off on the clearance before production begins.

4. Accountability

The Capsule Manufacturing Supervisor is accountable for ensuring that the line clearance procedure is followed before every production run. The QA Manager is responsible for reviewing the line clearance and approving it before manufacturing begins.

5. Procedure

5.1 Preparing for Line Clearance

Before starting the line clearance process, ensure the following preparations are completed:

1. Notify Relevant Departments
   1. Inform all relevant personnel (Production, QC, and Maintenance) of the upcoming line clearance procedure.
   2. Ensure that all required tools and cleaning materials are available for the procedure.
2. Shut Down the Previous Production Line
   1. Stop the production equipment from the previous batch and ensure that it is not running.
   2. Ensure that all machinery is safely powered off before starting the line clearance process.
3. Remove All Materials from the Line
   1. Ensure that all materials, including raw materials, capsules, and packaging materials, are removed from the production line and stored in the designated areas.

5.2 Conducting Line Clearance

Follow these steps to perform the actual line clearance:

1. Clean the Equipment
   1. Clean all machines, conveyors, and associated equipment to remove any residual materials from the previous batch.
   2. Ensure that cleaning materials used are appropriate for the equipment and product type.
   3. Document the cleaning procedure in the equipment cleaning log.
2. Check for Residual Materials
   1. Inspect all equipment and production areas for any residual materials, such as leftover powders, capsules, or packaging waste.
   2. Ensure that the floor, conveyors, and all surfaces are free from contamination.
3. Inspect Equipment Settings
   1. Ensure that all equipment settings are correct and suitable for the new batch, including adjusting the machine for the correct capsule size and fill weight.

5.3 Verifying Line Clearance

Once the line clearance process is complete, the following verification steps should be carried out:

1. Visual Inspection
   1. QC personnel should visually inspect the production area and equipment to ensure that the area is clear of any foreign objects or materials.
   2. Check that the equipment has been properly cleaned and is free from contamination.
2. Confirm Material Removal
   1. Ensure that all raw materials and products from the previous batch have been removed from the production area.
   2. Confirm that no materials have been left in the hoppers, filling stations, or other equipment.
3. Document Clearance Completion
   1. Document the completion of the line clearance procedure in the line clearance log. Include details such as the time of clearance, personnel involved, and any deviations from the procedure.
   2. Ensure that the log is signed by the responsible operator and supervisor to confirm that the process has been completed successfully.

5.4 Approving the Line Clearance

Once the line clearance has been completed and verified, the following steps must be taken before manufacturing begins:

1. Final QA Review
   1. The QA team should review the line clearance documentation and conduct a final check of the production area to ensure compliance with GMP standards.
   2. Ensure that the production area is clear and suitable for starting the next batch of capsules.
2. Approval of Line Clearance
   1. The QA Manager must sign off on the line clearance procedure, confirming that the production area is ready for the new batch.
   2. After approval, the production process can begin with the new batch of capsules.

5.5 Handling Deviations During Line Clearance

If any deviations from the SOP occur during the line clearance process, take the following steps:

1. Document the Deviation
   1. Record the deviation in the deviation log, including the nature of the deviation, the root cause, and corrective actions taken.
2. Implement Corrective Actions
   1. Implement corrective actions to address the cause of the deviation, such as additional cleaning, equipment adjustment, or re-training of personnel.
3. Review and Approve Corrective Actions
   1. The QA team should review and approve the corrective actions taken before allowing the production process to start.

5.6 Post-Line Clearance Actions

After the line clearance has been approved, the following actions should be taken:

1. Prepare for Production
   1. Ensure that all necessary materials, tools, and equipment are available and ready for the start of the new production batch.
   2. Confirm that the production schedule aligns with the available resources and equipment.
2. Documentation of Line Clearance
   1. Ensure that the line clearance log, deviation log (if applicable), and corrective action reports are completed and filed appropriately for future reference and auditing purposes.

6. Abbreviations

• SOP: Standard Operating Procedure
• GMP: Good Manufacturing Practice
• QC: Quality Control
• QA: Quality Assurance
• CAPA: Corrective and Preventive Action

7. Documents

1. Line Clearance Log (Annexure-1)
2. Deviation Log (Annexure-2)
3. Corrective Action Report (CAPA) (Annexure-3)

8. References

• USP <1163> – Pharmaceutical Dosage Forms: Capsules
• FDA Guidelines for Capsule Manufacturing
• International Conference on Harmonization (ICH) Guidelines for Pharmaceutical Manufacturing

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Line Clearance Log

Clearance Date	Batch Number	Operator Name	Inspection Results	Approval Status
01/02/2025	Batch 001	John Doe	Area cleared, no residual materials	Approved

Annexure-2: Deviation Log

Deviation ID	Description	Corrective Action Taken	Operator Name
DEV-001	Residue found on equipment	Additional cleaning performed	Jane Smith

Annexure-3: Corrective Action Report (CAPA)

CAPA ID	Root Cause	Corrective Action	Completion Date	Approval Status
CAPA-001	Inadequate cleaning procedure	Updated cleaning SOP	02/02/2025	Approved

Revision History:

Revision Date	Revision No.	Revision Details	Reason for Revision	Approved By
01/01/2024	1.0	Initial Version	New SOP Creation	QA Head
01/02/2025	2.0	Revised line clearance procedures	Standardization	QA Head