Standard Operating Procedure for Line Clearance in Manufacturing Areas

Department	Creams
SOP No.	SOP/CRM/050/2025
Supersedes	SOP/CRM/050/2022
Page No.	Page 1 of 7
Issue Date	02/11/2025
Effective Date	07/11/2025
Review Date	02/11/2026

1. Purpose

The purpose of this Standard Operating Procedure (SOP) is to define the process for line clearance in manufacturing areas during cream production. Line clearance is a critical process to ensure that the manufacturing area is free from any residual materials, equipment, or packaging materials from previous production runs. This ensures the integrity and quality of the next batch produced, preventing contamination and ensuring compliance with Good Manufacturing Practices (GMP).

2. Scope

This SOP applies to all cream manufacturing areas, including production lines, mixing areas, and filling stations in the Creams Department. It covers the procedures for cleaning, inspecting, and preparing the production area for the next batch of cream.

3. Responsibilities

• Production Team: Responsible for conducting line clearance before starting any new batch of cream production. This includes ensuring all equipment and materials are removed from the previous production and that the area is cleaned and inspected.
• Quality Control (QC): Responsible for verifying that line clearance procedures have been completed and that the area is free from any contamination before production begins. QC will also perform final inspections and document the line clearance process.
• Quality Assurance (QA): Ensures that line clearance procedures are followed according to this SOP and that all documentation is complete and accurate. QA is responsible for approving the line clearance and confirming that the area is ready for production.
• Maintenance Team: Responsible for ensuring that all equipment is properly cleaned and calibrated before it is used for the next batch. Maintenance may also assist in the physical cleaning process if required.

4. Accountability

The Head of Creams Manufacturing is responsible for ensuring that line clearance procedures are carried out before the start of each batch. The QA Manager is accountable for verifying the compliance of the line clearance process and ensuring proper documentation is completed.

5. Procedure

5.1 Preparation for Line Clearance

1. Prior to beginning line clearance, ensure that the previous batch of cream has been completed and that all products have been removed from the production line.
2. Ensure that all previous raw materials, packaging materials, and ingredients are removed from the area. Any remaining materials should be properly disposed of or stored according to waste management SOPs.
3. All equipment used in the previous production run should be either cleaned or tagged as “Out of Service” until properly cleaned.
4. Identify any materials or equipment that require special attention or cleaning (e.g., heat-sensitive equipment or materials that may degrade over time).

5.2 Cleaning of Manufacturing Area

1. Clean the production area thoroughly to remove any residual materials from the previous batch. This includes all surfaces, tools, equipment, and storage areas. Use appropriate cleaning agents and procedures as outlined in the cleaning SOPs for the specific equipment.
2. Ensure that all production tools and utensils are cleaned and sanitized, including mixing tanks, homogenizers, filling machines, and other relevant equipment.
3. After cleaning, verify that the area is free from visible residues. If any residue remains, perform additional cleaning and recheck the area.
4. Clean and inspect any waste disposal areas to ensure that they are clear and ready for use.

5.3 Inspection and Documentation

1. Once cleaning is completed, QC personnel should inspect the area and equipment to ensure that no residual material, cleaning agents, or contaminants remain in the production area.
2. Perform a final inspection of all tools and equipment used in the previous production run to ensure they have been properly cleaned and are ready for use in the next batch.
3. Document the cleaning and inspection process, including any deviations, corrective actions, or additional cleaning steps that were required. The documentation should include the batch number, date, time, and personnel involved.
4. If necessary, conduct environmental monitoring, such as air sampling or surface swabbing, to ensure the area is free from contamination.

5.4 Verification of Readiness

1. After the line clearance process is complete, verify that all necessary materials, tools, and equipment are ready and available for the next batch. This includes raw materials, packaging materials, and production tools.
2. Ensure that the MFR for the new batch is reviewed and that all required ingredients and equipment are prepared and available.
3. If any equipment or materials are missing or not ready, notify the appropriate department (e.g., Procurement or Production) to address the issue before starting the next batch.

5.5 Final Approval and Start of Production

1. Once the area is verified as ready, QA will provide final approval for the line clearance. This approval should be documented in the batch record.
2. After receiving approval, the Production Team can begin the preparation of the next batch of cream according to the MFR.
3. Ensure that the batch record is updated to reflect the completion of the line clearance and the start of the new production run.

5.6 Rejection of Line Clearance

1. If the line clearance is not properly completed, or if any contamination or residues are found, the area should be re-cleaned and inspected until it meets the required standards.
2. Any deviations from the line clearance process should be documented and investigated to identify root causes and prevent recurrence.

5.7 Documentation and Reporting

1. Maintain a line clearance log for each production run, including the following information:
   • Batch number
   • Date and time of line clearance
   • Personnel involved in the line clearance
   • Details of the inspection and cleaning process
   • Any deviations and corrective actions taken
2. Ensure that the line clearance log is reviewed and approved by the QA team before the production process begins.

5.8 Final Inspection and Monitoring

1. Conduct a final inspection of the manufacturing area after production begins to ensure no contamination occurs during the production process. Continue to monitor the cleanliness and safety of the production line throughout the batch process.
2. Ensure that any issues arising during production are documented and resolved promptly to maintain GMP compliance.

6. Abbreviations

• QC: Quality Control
• QA: Quality Assurance
• GMP: Good Manufacturing Practices
• MFR: Master Formula Record

7. Documents

1. Line Clearance Log (Annexure-1)
2. Batch Record (Annexure-2)
3. Cleaning and Inspection Report (Annexure-3)

8. References

• Good Manufacturing Practices (GMP) Guidelines – 21 CFR Part 211
• International Conference on Harmonisation (ICH) Q7 – Good Manufacturing Practice for Active Pharmaceutical Ingredients
• FDA Guidelines for Cosmetics 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

Batch Number	Line Clearance Time	Operator	Inspection Results	Corrective Actions
12345	08:00 AM	John Doe	Area clean, no contamination	No corrective action needed

Annexure-2: Batch Record

Batch Number	Process Step	Time	Operator
12345	Line Clearance	08:00 AM	Jane Smith

Annexure-3: Cleaning and Inspection Report

Batch Number	Cleaning Action	Inspection Findings	Corrective Actions
12345	Wiped surfaces, cleaned equipment	All surfaces clean, no residues	No corrective actions required

Revision History:

Revision Date	Revision No.	Revision Details	Reason for Revision	Approved By
01/03/2024	1.0	Initial Version	New SOP Creation	QA Head
01/03/2025	2.0	Format Revision and Updates	Standardization of Document	QA Head