expired materials are present in the packing area.

4. Accountability

The Manufacturing Manager is accountable for ensuring that the line clearance procedure is followed prior to each packing operation. The overall compliance with this SOP is overseen by the Quality Assurance (QA) Manager.

5. Procedure

5.1. Preparation for Line Clearance

1. Prior to beginning line clearance, the production team will gather the necessary cleaning materials and tools for the packing line. This may include cleaning agents, brushes, rags, and personal protective equipment (PPE).
2. The packing line should be turned off, and all relevant machinery should be disconnected from power sources for safety.
3. All materials, tools, and products from the previous production batch should be removed from the packing area and placed in the appropriate storage or disposal areas.
4. The area should be checked to ensure that no foreign objects or incorrect materials are left on the packing line. Any remaining products or materials from the previous batch should be documented in the Cleaning Log (Annexure-1).

5.2. Cleaning the Packing Line

1. The production team will clean all surfaces, machinery, and tools used in the packing line. The cleaning process should include:
   • Wiping down all surfaces that may have come into contact with the previous batch of aerosol products, including conveyors, packing machines, and any storage containers.
   • Disassembling and cleaning any parts of the machinery that may have held residual products (e.g., valve testers, crimpers, or filling stations).
   • Using appropriate cleaning agents that are compatible with the materials in use and ensuring that they are effective at removing any residues from previous batches.
2. After cleaning, all surfaces should be inspected by the QA team for cleanliness. If any residues or contamination are found, the cleaning procedure should be repeated.

5.3. Inspection and Verification

1. Once the packing line has been cleaned, the QA team will perform a thorough inspection of the packing area and equipment to ensure that no materials from previous batches remain. This includes:
   • Visually inspecting all surfaces for any foreign particles, dust, or product residues.
   • Checking for proper labeling and ensuring that no incorrect or expired packaging materials are present.
   • Verifying that the correct materials for the new batch are prepared and ready for use in the packing process.
2. If the packing line passes the inspection, the QA team will approve the line for use in packing the new batch of aerosol products. This approval will be documented in the Line Clearance Approval Log (Annexure-2).
3. If any issues are found during the inspection, the line clearance procedure should be repeated, and the issue should be documented in the Deviation Log (Annexure-3).

5.4. Documentation and Record Keeping

1. All line clearance activities must be documented to ensure traceability and compliance with GMP requirements. Documentation should include:
   • Cleaning Log (Annexure-1) detailing the cleaning process, materials used, and any actions taken during the process.
   • Line Clearance Approval Log (Annexure-2) confirming that the packing line has been cleared for use.
   • Deviation Log (Annexure-3) documenting any issues encountered during the line clearance process and corrective actions taken.
2. Records should be signed and dated by the personnel involved in the line clearance process. These records should be stored in the document management system for future reference and audits.
3. Line clearance records must be retained for a minimum of 3 years or as required by regulatory guidelines.

5.5. Reporting and Compliance

1. If any issues are identified during the line clearance process, they should be reported to the QA team for review. The QA team will ensure that corrective actions are taken, and the packing line is re-inspected before packing can begin.
2. The QA team will review the line clearance process during internal audits to ensure ongoing compliance with GMP and regulatory standards.

6. Abbreviations

• GMP: Good Manufacturing Practice
• QC: Quality Control
• PPE: Personal Protective Equipment
• SOP: Standard Operating Procedure
• QA: Quality Assurance

7. Documents

1. Cleaning Log (Annexure-1)
2. Line Clearance Approval Log (Annexure-2)
3. Deviation Log (Annexure-3)

8. References

This SOP is based on the following regulatory guidelines and industry standards:

• Good Manufacturing Practice (GMP) Guidelines
• FDA Code of Federal Regulations (CFR) Title 21, Part 211
• ISO 9001:2015 – Quality Management Systems

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Cleaning Log

Batch Number	Cleaning Date	Cleaning Method	Operator Name	Remarks
Batch-001	10/02/2025	Manual wipe down with cleaning agents	Rajesh Patel	All surfaces cleaned and free of residue

Annexure-2: Line Clearance Approval Log

Batch Number	Approval Date	Approving Authority	Comments
Batch-001	10/02/2025	Anjali Sharma	Line cleared for packing

Annexure-3: Deviation Log

Deviation ID	Deviation Description	Corrective Action	Responsible Person	Status
DEV-12345	Residual product on packing line	Re-cleaned the packing line	Rajesh Patel	Completed

12. Revision History:

Revision Date	Revision No.	Revision Details	Reason for Revision	Approved By	Page No.	Ref. Point No.	Details of Revision
01/01/2024	V 1.0	Initial Release	First Issue	Anjali Sharma	Page 1	[Ref Point]	First Release
01/01/2025	V 2.0	Updated line clearance procedure	To comply with updated GMP regulations	Anjali Sharma	Page 1	[Ref Point]	Updated procedures